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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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)
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Secondary ID [1]
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GS-US-219-0104
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Universal Trial Number (UTN)
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Trial acronym
AIR-BX2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in QOL-B Respiratory Symptoms Score at Day 28
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Day 28
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Secondary outcome [1]
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Change in QOL-B Respiratory Symptoms Score at Day 84
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Day 84
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Secondary outcome [2]
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Time to Protocol-Defined Exacerbation (PDE)
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Assessment method [2]
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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
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Timepoint [2]
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Baseline to Day 112
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2013
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Sample size
Target
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Accrual to date
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Final
274
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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Concord Hospital - Concord
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St Vincent's Hospital - Darlinghurst
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St George Hospital - Kogarah
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Royal Perth Hospital - Perth
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Westmead Hospital - Westmead
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Royal Adelaide Hospital - Adelaide
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Repatriation General Hospital - Daw Park
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Burnside War Memorial Hospital Pharmacy - Toorak Gardens
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Sir Charles Gairdner Hospital - Nedlands
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2139 - Concord
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2010 - Darlinghurst
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2217 - Kogarah
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6000 - Perth
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2145 - Westmead
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5000 - Adelaide
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5041 - Daw Park
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Recruitment postcode(s) [8]
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5065 - Toorak Gardens
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Recruitment postcode(s) [9]
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6009 - Nedlands
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Recruitment outside Australia
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01314716
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Trial related presentations / publications
Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.
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Public notes
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Contacts
Principal investigator
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Anne O'Donnell, MD
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Address
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Georgetown University Hospital
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01314716
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