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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01313624




Registration number
NCT01313624
Ethics application status
Date submitted
10/03/2011
Date registered
14/03/2011
Date last updated
16/04/2014

Titles & IDs
Public title
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Scientific title
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection
Secondary ID [1] 0 0
GS-US-219-0101
Universal Trial Number (UTN)
Trial acronym
AIR-BX1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZLI
Treatment: Drugs - Placebo

Experimental: AZLI-AZLI - Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.

Placebo Comparator: Placebo-AZLI - Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.


Treatment: Drugs: AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily

Treatment: Drugs: Placebo
Placebo to match AZLI administered via nebulizer three times daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in QOL-B Respiratory Symptoms Score at 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.
Timepoint [1] 0 0
Baseline to Day 28
Secondary outcome [1] 0 0
Change in QOL-B Respiratory Symptoms Score at 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.
Timepoint [1] 0 0
Baseline to Day 84
Secondary outcome [2] 0 0
Time to Protocol-Defined Exacerbation (PDE) - 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
Timepoint [2] 0 0
Baseline to Day 112

Eligibility
Key inclusion criteria
- Male/Female 18 years or older with non-CF bronchiectasis

- Chronic sputum production on most days

- Positive sputum culture for gram-negative organisms

- Must have met lung function requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of CF

- Hospitalized within 14 days prior to joining the study

- Previous exposure to AZLI

- Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study

- Must have met liver and kidney function requirements

- Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with
activity and at night was allowed)

- Treatment for nontuberculous mycobacteria infection or active mycobacterium
tuberculosis infection within 1 year of enrollment

- Other serious medical conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Woolcock Institute of Medical Research - Glebe
Recruitment hospital [4] 0 0
St. George Hospital - Kogarah
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Mater Adult Hospital - Brisbane
Recruitment hospital [8] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [9] 0 0
Royla Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Repatriation General Hospital - Daws Park
Recruitment hospital [11] 0 0
Respiratory Clinical Trials - Toorak Gardens
Recruitment hospital [12] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [13] 0 0
Peninsula Health - Frankston
Recruitment hospital [14] 0 0
Alfred Hospital - Westmead
Recruitment hospital [15] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2037 - Glebe
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4101 - Brisbane
Recruitment postcode(s) [8] 0 0
4032 - Chermside
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5041 - Daws Park
Recruitment postcode(s) [11] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3199 - Frankston
Recruitment postcode(s) [14] 0 0
3194 - Westmead
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and
gram-negative airway infection. Participants received two 28-day courses of either Aztreonam
for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a
28-day off-drug period. Following the two blinded courses, all participants received a 28-day
course of open-label AZLI then were followed for an additional 56 days.
Trial website
https://clinicaltrials.gov/show/NCT01313624
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan Barker, MD
Address 0 0
Oregon Health and Science University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications