Trial Outcomes & Findings for Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients (NCT NCT01270347)
NCT ID: NCT01270347
Last Updated: 2024-12-13
Results Overview
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug. An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to: Any symptom not previously reported by the patient (medical history) An exacerbation of a pre-existing illness An increase in frequency or intensity of a pre-existing episodic event or condition A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study Overdose of Study Drug
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
282 participants
Primary outcome timeframe
From start of study until end of the study (up to 168 days)
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
Tobramycin Inhalation Solution 300 mg/Aeroquin 240 mg
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase. Participants received 240 mg of Aeroquin by inhalation route, BID over 3 consecutive 56-day cycles (28days on treatment and 28 days off treatment) during extension phase.
|
Aeroquin 240 mg/Aeroquin 240 mg
Participants received 240 milligrams (mg) of Levofloxacin by inhalation route, twice daily (BID) over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase. Participants received 240 mg of Aeroquin by inhalation route, BID over 3 consecutive 56-day cycles (28days on treatment and 28 days off treatment) during extension phase.
|
|---|---|---|
|
Core Phase
STARTED
|
93
|
189
|
|
Core Phase
COMPLETED
|
83
|
166
|
|
Core Phase
NOT COMPLETED
|
10
|
23
|
|
Extension Phase
STARTED
|
32
|
56
|
|
Extension Phase
COMPLETED
|
26
|
47
|
|
Extension Phase
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Tobramycin Inhalation Solution 300 mg/Aeroquin 240 mg
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase. Participants received 240 mg of Aeroquin by inhalation route, BID over 3 consecutive 56-day cycles (28days on treatment and 28 days off treatment) during extension phase.
|
Aeroquin 240 mg/Aeroquin 240 mg
Participants received 240 milligrams (mg) of Levofloxacin by inhalation route, twice daily (BID) over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase. Participants received 240 mg of Aeroquin by inhalation route, BID over 3 consecutive 56-day cycles (28days on treatment and 28 days off treatment) during extension phase.
|
|---|---|---|
|
Core Phase
Adverse Event
|
1
|
6
|
|
Core Phase
Withdrawal by Subject
|
1
|
2
|
|
Core Phase
Lost to Follow-up
|
0
|
1
|
|
Core Phase
Miscellaneous
|
8
|
14
|
|
Extension Phase
Adverse Event
|
1
|
3
|
|
Extension Phase
Withdrawal by Subject
|
3
|
4
|
|
Extension Phase
Miscellaneous
|
2
|
2
|
Baseline Characteristics
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Baseline characteristics by cohort
| Measure |
Tobramycin Inhalation Solution 300 mg
n=90 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=182 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 9.00 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study until end of the study (up to 168 days)Population: Safety Population
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug. An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to: Any symptom not previously reported by the patient (medical history) An exacerbation of a pre-existing illness An increase in frequency or intensity of a pre-existing episodic event or condition A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study Overdose of Study Drug
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=90 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=182 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
90 participants
|
180 participants
|
PRIMARY outcome
Timeframe: Baseline, day 28Population: Intent-to-treat population included all participants randomized in the study.
FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error (SE) were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=93 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=189 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1)
|
0.38 percent predicted FEV1
Standard Error 1.262
|
2.24 percent predicted FEV1
Standard Error 1.019
|
SECONDARY outcome
Timeframe: Baseline, day 28Population: ITT Population
LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=93 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=189 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Percent Change From Baseline in Average Expired Flow Over the Middle Half of The FVC Maneuver (FEF25-75)
|
4.705 Percent change
Standard Error 8.8115
|
9.673 Percent change
Standard Error 2.2691
|
SECONDARY outcome
Timeframe: Baseline, day 28Population: ITT Population
LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=93 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=189 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Percent Change From Baseline in Forced Vital Capacity (FVC)
|
-1.152 Percent change
Standard Error 0.9191
|
0.417 Percent change
Standard Error 0.7441
|
SECONDARY outcome
Timeframe: Day 28Population: ITT population with available data at specified timepoint.
FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=88 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=172 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Number of Participants in Each Category of Relative Change in Percent Predicted FEV1
Moderate decline (decline >=10%, death, or lung transplant)
|
16 participants
|
30 participants
|
|
Number of Participants in Each Category of Relative Change in Percent Predicted FEV1
Mild decline (0% < decline < 10%)
|
26 participants
|
59 participants
|
|
Number of Participants in Each Category of Relative Change in Percent Predicted FEV1
Mild improvement (0% <= improvement < 10%)
|
37 participants
|
72 participants
|
|
Number of Participants in Each Category of Relative Change in Percent Predicted FEV1
Moderate improvement (10% <= improvement < 20%)
|
6 participants
|
6 participants
|
|
Number of Participants in Each Category of Relative Change in Percent Predicted FEV1
Significant improvement (improvement >= 20%)
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT population with available data.
FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=93 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=189 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Number of Participants in Each Category of Percent Change From Baseline in FEV1
Moderate decline (decline >=10%, death, or lung transplant)
|
13 participants
|
9 participants
|
|
Number of Participants in Each Category of Percent Change From Baseline in FEV1
Mild decline (0% < decline < 10%)
|
31 participants
|
48 participants
|
|
Number of Participants in Each Category of Percent Change From Baseline in FEV1
Mild improvement (0% <= improvement < 10%)
|
37 participants
|
103 participants
|
|
Number of Participants in Each Category of Percent Change From Baseline in FEV1
Moderate improvement (10% <= improvement < 20%)
|
8 participants
|
26 participants
|
|
Number of Participants in Each Category of Percent Change From Baseline in FEV1
Significant improvement (improvement >= 20%)
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, day 28Population: ITT population with available data at specified time point
Pseudomonas aeruginosa density was measured as log10 colony-forming units \[CFU\] per gram sputum.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=79 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=161 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Change From Baseline in Pseudomonas Aeruginosa Sputum Density
|
-1.19 log10 CFU per gram
Standard Error 0.243
|
-0.75 log10 CFU per gram
Standard Error 0.196
|
SECONDARY outcome
Timeframe: Baseline, day 28Population: ITT population with available data at specified time point.
Pseudomonas aeruginosa density was measured as log10 colony-forming units \[CFU\] per gram sputum.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=79 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=161 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density
> 1.5 log decrease
|
20 participants
|
32 participants
|
|
Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density
>= 0.5 to <= 1.5 log decrease
|
17 participants
|
36 participants
|
|
Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density
< 0.5 decrease and < 0.5 log increase
|
34 participants
|
61 participants
|
|
Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density
>= 0.5 to <= 1.5 log increase
|
4 participants
|
18 participants
|
|
Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density
> 1.5 log increase
|
4 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline, day 28Population: ITT population with available data at specified time point.
The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=91 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=186 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)
|
-1.31 Score on a scale
Standard Error 1.576
|
1.88 Score on a scale
Standard Error 1.278
|
SECONDARY outcome
Timeframe: Baseline, day 28Population: ITT population with available data at specified time point.
The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Tobramycin Inhalation Solution 300 mg
n=91 Participants
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
Levofloxacin Inhalation Solution 240 mg
n=186 Participants
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
|
|---|---|---|
|
Number of Participants in Each Category of Change From Baseline in the Respiratory Domain of CFQ-R
>= 4 increase
|
25 participants
|
81 participants
|
|
Number of Participants in Each Category of Change From Baseline in the Respiratory Domain of CFQ-R
< 4 increase and < 4 decrease
|
32 participants
|
49 participants
|
|
Number of Participants in Each Category of Change From Baseline in the Respiratory Domain of CFQ-R
>= 4 decrease
|
34 participants
|
56 participants
|
Adverse Events
Tobramycin Inhalation Solution 300 mg - Core Phase
Serious events: 29 serious events
Other events: 88 other events
Deaths: 0 deaths
Aeroquin 240 mg - Core Phase
Serious events: 40 serious events
Other events: 180 other events
Deaths: 0 deaths
Aeroquin 240 mg - Extension Phase
Serious events: 22 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tobramycin Inhalation Solution 300 mg - Core Phase
n=90 participants at risk
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase.
|
Aeroquin 240 mg - Core Phase
n=182 participants at risk
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase.
|
Aeroquin 240 mg - Extension Phase
n=88 participants at risk
Participants received 240 mg of Aeroquin by inhalation route route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during extension phase.
|
|---|---|---|---|
|
General disorders
Disease progression
|
26.7%
24/90 • Number of events 35 • From start of study until end of the study (up to 168 days)
Safety Population
|
17.0%
31/182 • Number of events 39 • From start of study until end of the study (up to 168 days)
Safety Population
|
18.2%
16/88 • Number of events 18 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Chest Pain
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Fatigue
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Bronchopneumonia
|
2.2%
2/90 • Number of events 3 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
2/182 • Number of events 2 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Pneumonia
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 2 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Sinusitis
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Distal ileal obstruction syndrome
|
1.1%
1/90 • Number of events 2 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.2%
2/90 • Number of events 2 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 2 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Nervous system disorders
Somnolence
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Psychiatric disorders
Depression
|
1.1%
1/90 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Chest Discomfort
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • Number of events 1 • From start of study until end of the study (up to 168 days)
Safety Population
|
Other adverse events
| Measure |
Tobramycin Inhalation Solution 300 mg - Core Phase
n=90 participants at risk
Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase.
|
Aeroquin 240 mg - Core Phase
n=182 participants at risk
Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase.
|
Aeroquin 240 mg - Extension Phase
n=88 participants at risk
Participants received 240 mg of Aeroquin by inhalation route route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during extension phase.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.8%
7/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
6.0%
11/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
3.4%
3/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Disease progression
|
63.3%
57/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
53.8%
98/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
51.1%
45/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Exercise tolerance decreased
|
15.6%
14/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
12.6%
23/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
12.5%
11/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Fatigue
|
27.8%
25/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
31.9%
58/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
20.5%
18/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Malaise
|
5.6%
5/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
3.4%
3/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
General disorders
Pyrexia
|
11.1%
10/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
9.3%
17/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
6.8%
6/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
11/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
9.3%
17/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
12.5%
11/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Sinusitis
|
8.9%
8/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.4%
8/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
3.4%
3/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
5/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
2.7%
5/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Investigations
Blood glucose increased
|
7.8%
7/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
2.2%
4/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Investigations
Breath sounds abnormal
|
1.1%
1/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.55%
1/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
5.7%
5/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Investigations
Forced expiratory volume decreased
|
16.7%
15/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
9.3%
17/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
15.9%
14/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Investigations
Pulmonary function test decreased
|
8.9%
8/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
7.7%
14/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
9.1%
8/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Investigations
Weight decreased
|
40.0%
36/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
31.3%
57/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
39.8%
35/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.8%
16/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
12.6%
23/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
11.4%
10/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
6/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
3.8%
7/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
1/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
5/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
5.5%
10/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.5%
4/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
25.3%
46/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
13.6%
12/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Nervous system disorders
Headache
|
6.7%
6/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
6.0%
11/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
3.4%
3/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Nervous system disorders
Sinus headache
|
14.4%
13/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
19.2%
35/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
13.6%
12/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
53.3%
48/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
57.7%
105/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
45.5%
40/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
5/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.4%
8/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.5%
4/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
15/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
11.5%
21/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
17.0%
15/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
5/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
1.1%
2/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
0.00%
0/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
18.9%
17/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
15.9%
29/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
13.6%
12/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
31.1%
28/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
32.4%
59/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
23.9%
21/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
2/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
7.7%
14/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.5%
4/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
20.0%
18/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
26.9%
49/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
15.9%
14/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
8.9%
8/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.4%
8/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
8.0%
7/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
35.6%
32/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
37.4%
68/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
36.4%
32/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
17.8%
16/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
14.3%
26/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
9.1%
8/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
44.4%
40/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
52.2%
95/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
42.0%
37/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
7/90 • From start of study until end of the study (up to 168 days)
Safety Population
|
3.3%
6/182 • From start of study until end of the study (up to 168 days)
Safety Population
|
4.5%
4/88 • From start of study until end of the study (up to 168 days)
Safety Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER