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

Brief Summary

Official 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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2013

Interventions Used in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in QOL-B Respiratory Symptoms Score at Day 28
    • Time Frame: Baseline to Day 28
      Safety Issue?: No

Secondary Measures

  • Change in QOL-B Respiratory Symptoms Score at Day 84
    • Time Frame: Baseline to Day 84
      Safety Issue?: No
  • Time to Protocol-Defined Exacerbation (PDE)
    • Time Frame: Baseline to Day 112
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alan Barker, MD, Principal Investigator, Oregon Health and Science University

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01313624