Clinical trial NCT00805025: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiectasis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)
timeFrame: Day -14 to Day 0
measure: Convergent Validity of the Respiratory Domain of the QOL-B
timeFrame: Day -14
Secondary outcomes:
measure: 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)
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Orange
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Olathe
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Chesterfield
country: United States
state: Missouri
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Tyler
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Gilead Sciences
name: Steve Lamola, MD
role: STUDY_DIRECTOR
References:
citation: Quittner AL, Marciel KK, Salathe MA, O'Donnell AE, Gotfried MH, Ilowite JS, Metersky ML, Flume PA, Lewis SA, McKevitt M, Montgomery AB, O'Riordan TG, Barker AF. A preliminary quality of life questionnaire-bronchiectasis: a patient-reported outcome measure for bronchiectasis. Chest. 2014 Aug;146(2):437-448. doi: 10.1378/chest.13-1891.