Brief Title
Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis
Official Title
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
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)
Secondary Outcome
Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)
Condition
Bronchiectasis
Intervention
AZLI
Study Arms / Comparison Groups
AZLI
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
89
Start Date
December 2008
Completion Date
October 2009
Primary Completion Date
October 2009
Eligibility 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Steve Lamola, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00805025
Organization ID
GS-US-219-0102
Responsible Party
Sponsor
Study Sponsor
Gilead Sciences
Study Sponsor
Steve Lamola, MD, Study Director, Gilead Sciences
Verification Date
February 2014