Phase 2
N=131
Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis
Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT00805025 ↗Enrolled (actual)
131
Serious AEs
4.5%
Results posted
Mar 2014
Primary outcome: Primary: Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) — 0.80 Intraclass Correlation Coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZLI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) |
0.80 | — |
| PRIMARY Convergent Validity of the Respiratory Domain of the QOL-B |
-0.19; 0.11; 0.16; -0.75 | — |
| SECONDARY 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) |
2.9 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00805025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.