A Study to See if AZLI (an Inhaled Antibiotic) is Effective in Treating Adults With Non-CF Bronchiectasis - AIR-BX2 - Full Text View

Purpose

The AIR-BX-2 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 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 disease for patients with CF and non-CF bronchiectasis, AZLI represents a potential treatment 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/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

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 (Day 28) ] [ 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:	172
Study Start Date:	April 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	July 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 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.

Detailed Description:

There will be 10 scheduled study visits. Planned visits include screening prior to randomization, evaluations at 14-day intervals during the first placebo-controlled course, and every 28 days subsequently.

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: 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
Last Updated:	February 13, 2013
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
Aztreonam

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013