Trial Outcomes & Findings for Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa (NCT NCT00757237)

Last Updated: 2011-07-04

Results Overview

Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

274 participants

Primary outcome timeframe

Baseline and end of treatment Course 1 (Day 28)

Results posted on

2011-07-04

Participant Flow

Seventy-three sites in the United States (US) and European Union (EU) enrolled a total of 274 participants in the study.

Of the 274 participants enrolled in the study, 273 were randomized between 07 August 2008 and 12 November 2009. One subject experienced a serious adverse event (SAE) between Visits 1 and 2; this subject did not receive study drug. A total of 268 participants received study drug (136 AZLI; 132 TIS).

Participant milestones

Participant milestones
Measure	AZLI (75 mg TID) AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Overall Study STARTED	137	136
Overall Study Treated	136	132
Overall Study COMPLETED	124	111
Overall Study NOT COMPLETED	13	25

Reasons for withdrawal

Reasons for withdrawal
Measure	AZLI (75 mg TID) AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Overall Study Lost to Follow-up	0	1
Overall Study Protocol Violation	0	2
Overall Study Physician Decision	2	3
Overall Study Withdrawal by Subject	8	12
Overall Study Safety or Tolerability	3	5
Overall Study Other	0	2

Baseline Characteristics

Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.	Total n=268 Participants Total of all reporting groups
Age Categorical >= 6 years to <= 12 years	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Age Categorical > 12 years to < 18 years	20 participants n=5 Participants	26 participants n=7 Participants	46 participants n=5 Participants
Age Categorical >= 18 years	108 participants n=5 Participants	101 participants n=7 Participants	209 participants n=5 Participants
Age Continuous	25.8 years STANDARD_DEVIATION 9.1 • n=5 Participants	25.1 years STANDARD_DEVIATION 9.0 • n=7 Participants	25.5 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	131 Participants n=7 Participants	261 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	50 participants n=7 Participants	94 participants n=5 Participants
Region of Enrollment Europe	92 participants n=5 Participants	82 participants n=7 Participants	174 participants n=5 Participants
Body Mass Index (BMI)	20.22 kg/m^2 STANDARD_DEVIATION 2.95 • n=5 Participants	20.49 kg/m^2 STANDARD_DEVIATION 2.82 • n=7 Participants	20.35 kg/m^2 STANDARD_DEVIATION 2.88 • n=5 Participants
Inhaled Tobramycin Use in the Previous 12 Months < 84 days	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Inhaled Tobramycin Use in the Previous 12 Months >= 84 days	115 participants n=5 Participants	113 participants n=7 Participants	228 participants n=5 Participants
Disease Severity <= 50% predicted	60 participants n=5 Participants	57 participants n=7 Participants	117 participants n=5 Participants
Disease Severity > 50% predicted	76 participants n=5 Participants	75 participants n=7 Participants	151 participants n=5 Participants
Forced Expiratory Volume (FEV1) Percent Predicted	52.30 percent STANDARD_DEVIATION 15.56 • n=5 Participants	52.24 percent STANDARD_DEVIATION 14.57 • n=7 Participants	52.27 percent STANDARD_DEVIATION 15.06 • n=5 Participants
Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score	62.87 units on a scale STANDARD_DEVIATION 20.42 • n=5 Participants	58.02 units on a scale STANDARD_DEVIATION 20.76 • n=7 Participants	60.44 units on a scale STANDARD_DEVIATION 20.69 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and end of treatment Course 1 (Day 28)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28	8.35 percent change in FEV1 percent predicted Standard Error 1.70	0.55 percent change in FEV1 percent predicted Standard Error 1.77

PRIMARY outcome

Timeframe: Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses	2.05 actual change in FEV1 percent predicted Standard Error 0.69	-0.66 actual change in FEV1 percent predicted Standard Error 0.72

SECONDARY outcome

Timeframe: Baseline and end of treatment Course 1 (Day 28)

Population: Analysis was based on participants with previous inhaled tobramycin use of \>= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.

Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of \>= 84 days in the previous 12 months.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=115 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=113 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization	10.04 percent change in FEV1 percent predicted Standard Error 1.56	0.54 percent change in FEV1 percent predicted Standard Error 1.57

SECONDARY outcome

Timeframe: Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Population: Analysis was based on participants with prior inhaled tobramycin use \>= 84 days in the previous 12 months using the ITT analysis set.

Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of \>=84 days in the previous 12 months.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=115 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=113 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization	3.26 actual change in FEV1 percent predicted Standard Error 0.65	-0.21 actual change in FEV1 percent predicted Standard Error 0.66

SECONDARY outcome

Timeframe: Day 0 to Day 168 (end of study)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee. Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events	NA days Interval 177.0 to NA = Not estimable; less than 50% of the participants had an event by the end of the study.	151 days Interval 113.0 to NA = Not estimable; less than 50% of the participants had an event by the end of the study.

SECONDARY outcome

Timeframe: Day 0 to Day 168 (end of study)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events. Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF. Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Time to First Respiratory Hospitalization	NA days NA = Not estimable; less than 50% of the participants had an event by the end of the study.	NA days NA = Not estimable; less than 50% of the participants had an event by the end of the study.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of treatment Course 1 (Day 28)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.

The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores \[units\]: 0-100; higher scores indicate fewer symptoms).

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28	8.20 Units on a scale Standard Error 1.68	2.59 Units on a scale Standard Error 1.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.

The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores \[units\]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses	6.30 units on a scale Standard Error 1.49	2.17 units on a scale Standard Error 1.54

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 20

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication's effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=130 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=126 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20	75.85 units on a scale Standard Error 4.58	61.73 units on a scale Standard Error 4.90

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day 168 (end of study)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Total Number of Respiratory Hospitalizations	40 hospitalizations	58 hospitalizations

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 through Day 168 (end of study)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)	84 events	121 events

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to Day 168 (end of study)

Population: Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).

Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored.

Outcome measures

Outcome measures
Measure	AZLI (75 mg TID) n=136 Participants AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 Participants TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)	NA days Interval 177.0 to NA = Not estimable; less than 50% of the participants had an event by the end of the study.	117 days Interval 102.0 to 169.0

Adverse Events

AZLI (75 mg TID)

Serious events: 42 serious events

Other events: 128 other events

Deaths: 0 deaths

TIS (300 mg BID)

Serious events: 44 serious events

Other events: 127 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Mark Bresnik, MD, Director, Clinical Research

Gilead Sciences, Inc.

Phone: (650) 522-5934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	AZLI (75 mg TID) n=136 participants at risk AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 participants at risk TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Gastrointestinal disorders Abdominal Discomfort	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Abdominal Distention	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	1.5% 2/132 • Number of events 2 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Abdominal Pain	3.7% 5/136 • Number of events 5 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Injury, poisoning and procedural complications Alcohol Poisoning	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Renal and urinary disorders Anuria	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Cardiac disorders Atrial Fibrillation	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Body Temperature Increased	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Breath Sounds Abnormal	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations C-Reactive Protein Increased	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Infections and infestations Catheter Related Infection	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Chest Discomfort	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Chest Pain	2.2% 3/136 • Number of events 3 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	1.5% 2/132 • Number of events 2 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Chills	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Nervous system disorders Coma	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Constipation	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Cough	19.9% 27/136 • Number of events 31 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	19.7% 26/132 • Number of events 30 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Cardiac disorders Cyanosis	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Metabolism and nutrition disorders Decreased Appetite	2.2% 3/136 • Number of events 3 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	1.5% 2/132 • Number of events 2 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	1.5% 2/136 • Number of events 3 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.4% 10/136 • Number of events 13 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	11.4% 15/132 • Number of events 17 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Exercise Tolerance Decreased	4.4% 6/136 • Number of events 6 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	2.3% 3/132 • Number of events 3 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Fatigue	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	2.3% 3/132 • Number of events 3 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Injury, poisoning and procedural complications Feeding Tube Complication	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Forced Expiratory Volume Decreased	2.2% 3/136 • Number of events 3 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Glycosylated Haemoglobin Increased	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.7% 5/136 • Number of events 6 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	2.3% 3/132 • Number of events 4 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Nervous system disorders Headache	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Vascular disorders Hyperaemia	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Psychiatric disorders Insomnia	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Nervous system disorders Lethargy	0.74% 1/136 • Number of events 2 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.76% 1/132 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Malaise	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.74% 1/136 • Number of events 2 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Nasal Mucosal Disorder	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Nausea	0.74% 1/136 • Number of events 1 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	0.00% 0/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Oedema Peripheral	0.00% 0/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	1.5% 2/132 • Number of events 2 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.

Other adverse events
Measure	AZLI (75 mg TID) n=136 participants at risk AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.	TIS (300 mg BID) n=132 participants at risk TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
Gastrointestinal disorders Abdominal Pain	11.0% 15/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	6.1% 8/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Musculoskeletal and connective tissue disorders Arthalgia	7.4% 10/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	1.5% 2/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Musculoskeletal and connective tissue disorders Back Pain	5.1% 7/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	3.0% 4/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Breath Sounds Abnormal	5.1% 7/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	10.6% 14/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Chest Discomfort	9.6% 13/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	9.8% 13/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Chest Pain	4.4% 6/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	6.1% 8/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Cough	67.6% 92/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	72.0% 95/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Metabolism and nutrition disorders Decreased Appetite	12.5% 17/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	12.9% 17/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Diarrhoea	2.9% 4/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	9.1% 12/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.7% 5/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	6.1% 8/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Dyspnoea	19.1% 26/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	21.2% 28/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Exercise Tolerance Decreased	14.7% 20/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	18.2% 24/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Fatigue	16.9% 23/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	16.7% 22/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Forced Expiratory Volume Decreased	5.1% 7/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	3.8% 5/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Haemoptysis	22.1% 30/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	15.2% 20/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Nervous system disorders Headache	20.6% 28/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	20.5% 27/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Musculoskeletal and connective tissue disorders Myalgia	6.6% 9/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	4.5% 6/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	21.3% 29/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	19.7% 26/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Nausea	9.6% 13/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	7.6% 10/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	25.0% 34/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	28.0% 37/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Pain	6.6% 9/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	3.0% 4/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Productive Cough	46.3% 63/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	50.8% 67/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Investigations Pulmonary Function Test Decreased	4.4% 6/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	11.4% 15/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
General disorders Pyrexia	25.0% 34/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	27.3% 36/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Rales	21.3% 29/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	24.2% 32/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	11.0% 15/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	12.1% 16/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Rhinitis	2.9% 4/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	5.3% 7/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	17.6% 24/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	25.0% 33/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	2.2% 3/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	6.1% 8/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Gastrointestinal disorders Vomiting	8.8% 12/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	10.6% 14/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Respiratory, thoracic and mediastinal disorders Wheezing	9.6% 13/136 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.	11.4% 15/132 • Treatment-emergent adverse events (AEs) were collected continuously from Day 0 (first dose) through Day 168 (Week 24). An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by a participant at any time during study, whether or not the AE was considered related to study participation or procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.