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

An Open-Label, Multicenter Trial to Validate the Quality of Life Questionnaire-Bronchiectasis and to Evaluate Perception of Symptom Improvement Following One Course of Aztreonam for Inhalation Solution (AZLI) in Subjects With Bronchiectasis and Gram-negative Bacteria in the Airways

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.

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)