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

Completed · Phase 2

Conditions studied: Bronchiectasis

In brief

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.

Key facts

Study ID

NCT00805025

Run by

Gilead Sciences

People needed

89

Starts

2008-12-01

Expected to finish

2009-10-01

Last updated by the study team

2014-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Orange, California, United States
• Study site — Denver, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Olathe, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Mineola, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Tyler, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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