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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/NCT01314716




Registration number
NCT01314716
Ethics application status
Date submitted
11/03/2011
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/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
Secondary ID [1] 0 0
GS-US-219-0104
Universal Trial Number (UTN)
Trial acronym
AIR-BX2
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
1/07/2013
Sample size
Target
Accrual to date
Final
274
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Repatriation General Hospital - Daw Park
Recruitment hospital [8] 0 0
Burnside War Memorial Hospital Pharmacy - Toorak Gardens
Recruitment hospital [9] 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
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5041 - Daw Park
Recruitment postcode(s) [8] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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District of Columbia
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Florida
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Georgia
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Illinois
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Iowa
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Kentucky
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Maryland
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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Texas
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Utah
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Washington
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Wisconsin
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Ontario
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France
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Gap, PACA
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France
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Marseille
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France
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Montpellier Cedex 05
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Nice
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France
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Pessac
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France
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Toulouse
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Germany
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Berlin-Charlottenburg (Westend)
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Germany
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Berlin
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Germany
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Freiburg
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Germany
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Giessen
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Germany
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Hannover
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Germany
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Homburg
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Jena
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Leipzig
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Germany
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Munich
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Italy
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Ferrara
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Milan
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Italy
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Modena
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Italy
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Naples
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Italy
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Pisa
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Italy
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Verona
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Netherlands
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Alkmaar
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Rotterdam
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Barcelona
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Girona
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Madrid
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Valencia
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Cambridgeshire
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Edinburgh
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Exeter
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Newcastle upon Tyne
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Sheffield
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Torquay, Devon
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Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The AIR-BX2 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/NCT01314716
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne O'Donnell, MD
Address 0 0
Georgetown University Hospital
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/NCT01314716