COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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,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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
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
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Belgium
State/province [20] 0 0
Brussels
Country [21] 0 0
Belgium
State/province [21] 0 0
Edegem
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
France
State/province [25] 0 0
Gap, PACA
Country [26] 0 0
France
State/province [26] 0 0
Marseille
Country [27] 0 0
France
State/province [27] 0 0
Montpellier Cedex 05
Country [28] 0 0
France
State/province [28] 0 0
Nice
Country [29] 0 0
France
State/province [29] 0 0
Pessac
Country [30] 0 0
France
State/province [30] 0 0
Toulouse
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin-Charlottenburg (Westend)
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Freiburg
Country [34] 0 0
Germany
State/province [34] 0 0
Giessen
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Homburg
Country [37] 0 0
Germany
State/province [37] 0 0
Jena
Country [38] 0 0
Germany
State/province [38] 0 0
Leipzig
Country [39] 0 0
Germany
State/province [39] 0 0
Munich
Country [40] 0 0
Italy
State/province [40] 0 0
Ferrara
Country [41] 0 0
Italy
State/province [41] 0 0
Milan
Country [42] 0 0
Italy
State/province [42] 0 0
Modena
Country [43] 0 0
Italy
State/province [43] 0 0
Naples
Country [44] 0 0
Italy
State/province [44] 0 0
Pisa
Country [45] 0 0
Italy
State/province [45] 0 0
Verona
Country [46] 0 0
Netherlands
State/province [46] 0 0
Alkmaar
Country [47] 0 0
Netherlands
State/province [47] 0 0
Rotterdam
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Girona
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Cambridgeshire
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Edinburgh
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Exeter
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Newcastle upon Tyne
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Sheffield
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Torquay, Devon
Country [58] 0 0
United Kingdom
State/province [58] 0 0
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/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
Other publications