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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
Baseline to Day 28
Secondary outcome [1] 0 0
Change in QOL-B Respiratory Symptoms Score at Day 84
Timepoint [1] 0 0
Baseline to Day 84
Secondary outcome [2] 0 0
Time to Protocol-Defined Exacerbation (PDE)
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
Sex
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
266
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01313624