Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01314716
First received: March 11, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Bronchiectasis
Drug: AZLI
Drug: Placebo
Phase 3

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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change in QOL-B Respiratory Symptoms Score at Day 28 [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in QOL-B Respiratory Symptoms Score at Day 84 [ Time Frame: Baseline to Day 84 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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


Enrollment: 274
Study Start Date: April 2011
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314716

  Show 85 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Anne O'Donnell, MD Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01314716     History of Changes
Other Study ID Numbers: GS-US-219-0104
Study First Received: March 11, 2011
Results First Received: March 7, 2014
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Netherlands: Medicines Evaluation Board (MEB)
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014