Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Bronchiectasis

Treatments: Drug: AZLI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805025

GS-US-219-0102

Details and patient eligibility

About

Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary function testing and other standard procedures.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent prior to any study-related procedures
• Ability to read and understand the English language
• Bronchiectasis confirmed by CT scan of the chest
• Previous treatment with antibiotics for bronchiectasis
• Documented history of positive sputum culture for a gram-negative organism within 5 years
• Positive sputum culture for a gram-negative organism at first visit (Day -14)

Exclusion criteria

• Hospitalization or hemoptysis > 30 mL within 14 days of first visit (Day -14)
• Antibiotic use for respiratory symptoms within 14 days of first visit (Day -14), excluding chronic, stable azithromycin use
• Change in corticosteroid or bronchodilator regimen within 14 days of first visit (Day -14)
• Forced expiratory volume in 1 second (FEV1) < 25% predicted approximately 15 minutes following use of a bronchodilator at first visit (Day -14)
• Cigarette smoking within 6 months of first visit (Day -14)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

AZLI

Experimental group

Description:

Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.

Treatment:

Drug: AZLI