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A Study to See if AZLI (an Inhaled Antibiotic) is Effective in Treating Adults With Non-CF Bronchiectasis - AIR-BX1

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01313624
First received: March 10, 2011
Last updated: November 19, 2012
Last verified: August 2012
History of Changes
  Purpose

The AIR-BX-1 study is for people who have been diagnosed with non-CF bronchiectasis and have gram-negative airway infection. This is a randomized study, the participants will be selected by chance (like flipping a coin) to receive one of two treatments (AZLI or Placebo). This is a double-blind study which means participants and their study doctors will not know what treatment they are assigned to receive. Participants will receive two 28-day courses of either AZLI or placebo taken 3 times a day. Each course has a 28 day off-drug period. Following the two blinded courses, all participants will receive AZLI for the third 28-day course.

Based on observed safety and effectiveness of AZLI in the adult CF population, and due to the similarities in the lung diseases for patients with CF and non-CF bronchiectasis, AZLI represents a potential treatment option for people with non-CF bronchiectasis and infection of the airways.


Condition Intervention Phase
Bronchiectasis
 Drug: Aztreonam for Inhalation Solution (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 in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX1)

Resource links provided by NLM:

Drug Information available for: Aztreonam
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change in QOL-B Respiratory Symptoms Score. [ Time Frame: Baseline to end of treatment course 1 (28 days) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change in QOL-B Respiratory Symptoms and Physical Functioning Scores. [ Time Frame: Baseline to end of treatment course 1 and 2. ] [ Designated as safety issue: No ]
  • Time to Exacerbation [ Time Frame: From baseline to open label treatment (4 months) ] [ Designated as safety issue: No ]
    Time to protocol-defined exacerbation prior to open-label AZLI treatment.


Estimated Enrollment: 266
Study Start Date: April 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZLI Drug: Aztreonam for Inhalation Solution (AZLI)
75 mg Aztreonam lysine monohydrate reconstituted with diluent and administered via nebulizer, three times a day for a 28 day period.
Placebo Comparator: Sugar and Saline Solution Drug: Placebo
Sugar powder, reconstituted with diluent and administered via nebulizer, three times a day for a 28 day period.

  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 meet lung function requirements

Exclusion Criteria:

  • History of CF
  • Hospitalized within 14 days prior to joining the study
  • Previous exposure to AZLI for inhalation
  • Pregnant, breastfeeding or unwilling to follow contraceptive measures for the study
  • Must meet liver and kidney function requirements
  • Continuous oxygen use of greater than 2 Liters per minute (supplemental oxygen with activity and at night is allowed)
  • Current treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
  • Other serious medical conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313624

  Show 60 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Alan Barker, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01313624     History of Changes
Other Study ID Numbers: GS-US-219-0101
Study First Received: March 10, 2011
Last Updated: November 19, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Aztreonam
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013