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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Bronchiectasis

Treatments: Drug: Placebo; Drug: AZLI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01314716

GS-US-219-0104

Details and patient eligibility

About

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.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

274 participants in 2 patient groups, including a placebo group

AZLI-AZLI

Experimental group

Description:

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.

Treatment:

Drug: AZLI

Placebo-AZLI

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: AZLI