Trial Outcomes & Findings for Aztreonam Lysine for Pseudomonas Infection Eradication Study (NCT NCT01375049)
NCT ID: NCT01375049
Last Updated: 2014-07-17
Results Overview
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Day 28 to Day 196
Results posted on
2014-07-17
Participant Flow
Participants were enrolled at a total of 46 study sites in the United States and Europe. The first participant was screened on 04 October 2011. The last participant observation occurred on 29 May 2013.
109 participants were screened; 105 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
Participant milestones
| Measure |
AZLI
Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
AZLI
Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol-Specified Withdrawal Criteria
|
45
|
Baseline Characteristics
Aztreonam Lysine for Pseudomonas Infection Eradication Study
Baseline characteristics by cohort
| Measure |
AZLI
n=105 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|
|
Age, Continuous
|
6.26 years
STANDARD_DEVIATION 4.743 • n=5 Participants
|
|
Age, Customized
3 months to < 2 years
|
24 participants
n=5 Participants
|
|
Age, Customized
≥ 2 years to < 6 years
|
25 participants
n=5 Participants
|
|
Age, Customized
≥ 6 years to < 18 years
|
56 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
99 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted to be Recorded
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
93 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
|
Weight
|
24.8 kg
STANDARD_DEVIATION 15.69 • n=5 Participants
|
|
Height
|
113.9 cm
STANDARD_DEVIATION 33.02 • n=5 Participants
|
|
BMI
|
17.1 kg/m^2
STANDARD_DEVIATION 2.57 • n=5 Participants
|
|
Presence of Pseudomonas aeruginosa (PA)
Present at baseline
|
45 participants
n=5 Participants
|
|
Presence of Pseudomonas aeruginosa (PA)
Absent at baseline
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 to Day 196Population: Evaluable Analysis Set
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=79 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)
|
58.2 percentage of participants
Interval 47.4 to 69.1
|
—
|
PRIMARY outcome
Timeframe: Day 28 to Day 196Population: Sensitivity Analysis Set
The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=98 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)
|
46.9 percentage of participants
Interval 37.1 to 56.8
|
—
|
SECONDARY outcome
Timeframe: Baseline to Days 28, 56, 112, and 196Population: Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.
Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=25 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
n=27 Participants
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Change From Baseline in FEV1% Predicted
Change at Day 28 (n=25 [met], 26 [did not meet])
|
-0.23 percentage of FEV1% predicted
Standard Deviation 10.373
|
-0.38 percentage of FEV1% predicted
Standard Deviation 12.347
|
|
Change From Baseline in FEV1% Predicted
Change at Day 56 (n=25 [met], 26 [did not meet])
|
-0.20 percentage of FEV1% predicted
Standard Deviation 10.949
|
-4.24 percentage of FEV1% predicted
Standard Deviation 7.513
|
|
Change From Baseline in FEV1% Predicted
Change at Day 112 (n=25 [met], 19 [did not meet])
|
0.32 percentage of FEV1% predicted
Standard Deviation 9.830
|
-5.10 percentage of FEV1% predicted
Standard Deviation 7.948
|
|
Change From Baseline in FEV1% Predicted
Change at Day 196 (n=25 [met], 8 [did not meet])
|
-2.47 percentage of FEV1% predicted
Standard Deviation 8.895
|
-8.85 percentage of FEV1% predicted
Standard Deviation 11.510
|
SECONDARY outcome
Timeframe: Baseline to Days 28, 56, 112, and 196Population: Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.
Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=25 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
n=31 Participants
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Change From Baseline in CFQ-R RSS Score
Change at Day 28 (n=24 [met], 29 [did not meet])
|
8.33 units on a scale
Standard Deviation 15.883
|
5.36 units on a scale
Standard Deviation 8.937
|
|
Change From Baseline in CFQ-R RSS Score
Change at Day 56 (n=24 [met], 27 [did not meet])
|
6.37 units on a scale
Standard Deviation 16.433
|
6.17 units on a scale
Standard Deviation 11.040
|
|
Change From Baseline in CFQ-R RSS Score
Change at Day 112 (n=24 [met], 21 [did not meet])
|
5.79 units on a scale
Standard Deviation 14.397
|
1.46 units on a scale
Standard Deviation 14.636
|
|
Change From Baseline in CFQ-R RSS Score
Change at Day 196 (n=24 [met], 10 [did not meet])
|
6.13 units on a scale
Standard Deviation 18.002
|
5.83 units on a scale
Standard Deviation 9.663
|
SECONDARY outcome
Timeframe: Days 28, 56, 112, and 196Population: Participants from the Full Analysis Set who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course were included in the analysis at all time points.
The percentage of participants with a PA-negative culture was summarized at each visit.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=101 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Percentage of Participants With PA-negative Cultures
Day 28
|
89.1 percentage of participants
|
—
|
|
Percentage of Participants With PA-negative Cultures
Day 56
|
75.2 percentage of participants
|
—
|
|
Percentage of Participants With PA-negative Cultures
Day 112
|
63.4 percentage of participants
|
—
|
|
Percentage of Participants With PA-negative Cultures
Day 196
|
47.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 196Population: Full Analysis Set
The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=105 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Use of Additional (Non-study) Antipseudomonal Antibiotics
On-treatment
|
1.9 percentage of participants
|
—
|
|
Use of Additional (Non-study) Antipseudomonal Antibiotics
Posttreatment
|
43.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Days 28, 56, 112, and 196Population: Full Analysis Set
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=105 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Change From Baseline in Weight
Change at Day 28 (On-Treatment, n = 104)
|
0.3 kg
Standard Deviation 0.70
|
—
|
|
Change From Baseline in Weight
Change at Day 56 (Posttreatment, n = 101)
|
0.5 kg
Standard Deviation 0.72
|
—
|
|
Change From Baseline in Weight
Change at Day 112 (Posttreatment, n = 90)
|
0.8 kg
Standard Deviation 1.02
|
—
|
|
Change From Baseline in Weight
Change at Day 196 (Posttreatment, n = 69)
|
1.5 kg
Standard Deviation 3.8
|
—
|
SECONDARY outcome
Timeframe: Baseline to Days 28, 56, 112, and 196Population: Full Analysis Set
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=105 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Change From Baseline in Height
Change at Day 28 (On-Treatment, n = 104)
|
0.6 cm
Standard Deviation 0.87
|
—
|
|
Change From Baseline in Height
Change at Day 56 (Posttreatment, n = 101)
|
1.4 cm
Standard Deviation 1.27
|
—
|
|
Change From Baseline in Height
Change at Day 112 (Posttreatment, n = 90)
|
2.6 cm
Standard Deviation 2.00
|
—
|
|
Change From Baseline in Height
Change at Day 196 (Posttreatment, n = 69)
|
4.5 cm
Standard Deviation 2.86
|
—
|
SECONDARY outcome
Timeframe: Baseline to Days 28, 56, 112, and 196Population: Full Analysis Set
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=105 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Change From Baseline in Body Mass Index (BMI)
Change at Day 28 (On-Treatment, n = 104)
|
0.1 kg/m^2
Standard Deviation 0.57
|
—
|
|
Change From Baseline in Body Mass Index (BMI)
Change at Day 56 (Posttreatment, n = 101)
|
0.1 kg/m^2
Standard Deviation 0.71
|
—
|
|
Change From Baseline in Body Mass Index (BMI)
Change at Day 112 (Posttreatment, n = 90)
|
0.0 kg/m^2
Standard Deviation 0.97
|
—
|
|
Change From Baseline in Body Mass Index (BMI)
Change at Day 196 (Posttreatment, n = 69)
|
0.0 kg/m^2
Standard Deviation 0.93
|
—
|
SECONDARY outcome
Timeframe: Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)Population: Participants in the Full Analysis Set \< 6 years of age with evaluable PK profiles were analyzed.
The plasma concentration of aztreonam for participants \< 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28.
Outcome measures
| Measure |
AZLI - Evaluable Analysis Set
n=49 Participants
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196.
|
AZLI - Did Not Meet Primary Efficacy Endpoint
This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|---|
|
Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam
Day 1 (1 hour postdose, n = 40)
|
578 ng/mL
Standard Deviation 560.0
|
—
|
|
Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam
Day 28 (immediately prior to dosing, n = 43)
|
125 ng/mL
Standard Deviation 166.3
|
—
|
Adverse Events
AZLI
Serious events: 8 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZLI
n=105 participants at risk
Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|
|
Hepatobiliary disorders
Hepatitus acute
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
|
Infections and infestations
Infectious mononucleosis
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
|
Infections and infestations
Pseudomonas infection
|
1.9%
2/105 • Baseline to Day 28 plus 30 days
|
|
Infections and infestations
Viral infection
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
|
Investigations
Pseudomonas test positive
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.95%
1/105 • Baseline to Day 28 plus 30 days
|
Other adverse events
| Measure |
AZLI
n=105 participants at risk
Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.
Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
7/105 • Baseline to Day 28 plus 30 days
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
7/105 • Baseline to Day 28 plus 30 days
|
|
General disorders
Pyrexia
|
14.3%
15/105 • Baseline to Day 28 plus 30 days
|
|
Infections and infestations
Rhinitis
|
7.6%
8/105 • Baseline to Day 28 plus 30 days
|
|
Investigations
Pseudomonas test positive
|
19.0%
20/105 • Baseline to Day 28 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
42/105 • Baseline to Day 28 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.5%
10/105 • Baseline to Day 28 plus 30 days
|
Additional Information
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 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