Trial · NCT01313624

Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

NCT01313624, Phase 3, Completed, Gilead Sciences; results first posted 2014-04-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis. Trials, record NCT01313624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01313624

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
NCT number: NCT01313624
Status: Completed
Phases: Phase 3
Enrollment: 266 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Bronchiectasis
Interventions: AZLI, Placebo
First posted: 2011-03-14
Last updated: 2014-04-16
Results first posted: 2014-04-16

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in QOL-B Respiratory Symptoms Score at Day 28	Baseline to Day 28	The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Secondary	Change in QOL-B Respiratory Symptoms Score at Day 84	Baseline to Day 84	The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Secondary	Time to Protocol-Defined Exacerbation (PDE)	Baseline to Day 112	Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria. * Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough * Minor Criteria: fever (\> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased \> 10% from baseline; new or increased hemoptysis

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in QOL-B Respiratory Symptoms Score at Day 28	Baseline to Day 28	Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.	units on a scale	MEAN
SECONDARY	Change in QOL-B Respiratory Symptoms Score at Day 84	Baseline to Day 84	Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.	units on a scale	MEAN
SECONDARY	Time to Protocol-Defined Exacerbation (PDE)	Baseline to Day 112	ITT Analysis Set	days	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in QOL-B Respiratory Symptoms Score at Day 28	AZLI-AZLI	7.4	Standard Deviation 21.37	units on a scale
Change in QOL-B Respiratory Symptoms Score at Day 28	Placebo-AZLI	5.7	Standard Deviation 13.62	units on a scale
Change in QOL-B Respiratory Symptoms Score at Day 84	AZLI-AZLI	7.4	Standard Deviation 21.67	units on a scale
Change in QOL-B Respiratory Symptoms Score at Day 84	Placebo-AZLI	4.7	Standard Deviation 17.24	units on a scale
Time to Protocol-Defined Exacerbation (PDE)	AZLI-AZLI	NA	95% Confidence Interval NA to NA	days
Time to Protocol-Defined Exacerbation (PDE)	Placebo-AZLI	120	95% Confidence Interval 117.0 to NA	days

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-Blind Phase	STARTED	AZLI-AZLI	134
Double-Blind Phase	STARTED	Placebo-AZLI	132
Double-Blind Phase	COMPLETED	AZLI-AZLI	96
Double-Blind Phase	COMPLETED	Placebo-AZLI	122
Double-Blind Phase	NOT COMPLETED	AZLI-AZLI	38
Double-Blind Phase	NOT COMPLETED	Placebo-AZLI	10
Open-Label Phase	STARTED	AZLI-AZLI	96
Open-Label Phase	STARTED	Placebo-AZLI	122
Open-Label Phase	COMPLETED	AZLI-AZLI	92
Open-Label Phase	COMPLETED	Placebo-AZLI	109

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events304

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cough	Respiratory, thoracic and mediastinal disorders	AZLI-AZLI (Double-Blind)	69	134
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo-AZLI (Double-Blind)	57	132
other	Cough	Respiratory, thoracic and mediastinal disorders	AZLI-AZLI (Open-Label)	35	96
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo-AZLI (Open-Label)	50	122
other	Sputum Increased	Respiratory, thoracic and mediastinal disorders	AZLI-AZLI (Double-Blind)	62	134
other	Sputum Increased	Respiratory, thoracic and mediastinal disorders	Placebo-AZLI (Double-Blind)	48	132
other	Sputum Increased	Respiratory, thoracic and mediastinal disorders	AZLI-AZLI (Open-Label)	29	96
other	Sputum Increased	Respiratory, thoracic and mediastinal disorders	Placebo-AZLI (Open-Label)	36	122
other	Sputum discoloured	Respiratory, thoracic and mediastinal disorders	AZLI-AZLI (Double-Blind)	42	134
other	Sputum discoloured	Respiratory, thoracic and mediastinal disorders	Placebo-AZLI (Double-Blind)	33	132

1 to 10 of 304Source ClinicalTrials.gov

See all 304 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZLI-AZLI (Double-Blind)
Total, all-cause mortality	Placebo-AZLI (Double-Blind)
Total, all-cause mortality	AZLI-AZLI (Open-Label)
Total, all-cause mortality	Placebo-AZLI (Open-Label)
Total, other adverse events	AZLI-AZLI (Double-Blind)	116	134
Total, other adverse events	Placebo-AZLI (Double-Blind)	102	132
Total, other adverse events	AZLI-AZLI (Open-Label)	54	96
Total, other adverse events	Placebo-AZLI (Open-Label)	76	122
Total, serious adverse events	AZLI-AZLI (Double-Blind)	28	134
Total, serious adverse events	Placebo-AZLI (Double-Blind)	13	132

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25154045	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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