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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Aztreonam

Criteria

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)