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Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX1)

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ClinicalTrials.gov Identifier: NCT01313624
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 10, 2011
First Posted Date  ICMJE March 14, 2011
Results First Submitted Date  ICMJE March 7, 2014
Results First Posted Date  ICMJE April 16, 2014
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Change in QOL-B Respiratory Symptoms Score at Day 28 [ Time Frame: Baseline to 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
Change in QOL-B Respiratory Symptoms Score. [ Time Frame: Baseline to end of treatment course 1 (28 days) ]
Change in the Respiratory Symptoms score on the Quality of Life Questionaire-Bronchiectasis (QOL-B) from baseline to the end of the placebo-controlled course 1 treatment with AZLI or placebo (Day 28).
Change History Complete list of historical versions of study NCT01313624 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • Change in QOL-B Respiratory Symptoms Score at Day 84 [ Time Frame: Baseline to 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.
  • Time to Protocol-Defined Exacerbation (PDE) [ Time Frame: Baseline to Day 112 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
  • Change in QOL-B Respiratory Symptoms and Physical Functioning Scores. [ Time Frame: Baseline to end of treatment course 1 and 2. ]
  • Time to Exacerbation [ Time Frame: From baseline to open label treatment (4 months) ]
    Time to protocol-defined exacerbation prior to open-label AZLI treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bronchiectasis
Intervention  ICMJE
  • Drug: AZLI
    AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
  • Drug: Placebo
    Placebo to match AZLI administered via nebulizer three times daily
Study Arms  ICMJE
  • 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.
    Intervention: Drug: AZLI
  • 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.
    Interventions:
    • Drug: AZLI
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
266
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2011)
172
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01313624
Other Study ID Numbers  ICMJE GS-US-219-0101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alan Barker, MD Oregon Health and Science University
PRS Account Gilead Sciences
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP