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
1 other identifier
interventional
89
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2008
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 5, 2008
CompletedFirst Posted
Study publicly available on registry
December 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
March 20, 2014
CompletedMarch 20, 2014
February 1, 2014
10 months
December 5, 2008
September 9, 2013
February 3, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)
Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability. The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Day -14 to Day 0
Convergent Validity of the Respiratory Domain of the QOL-B
Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.
Day -14
Secondary Outcomes (1)
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)
Day 0 to Day 28
Study Arms (1)
AZLI
EXPERIMENTALParticipants 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.
Interventions
75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (24)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Denver, Colorado, 80206, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
New Haven, Connecticut, 06519, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Olathe, Kansas, 66061, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Chesterfield, Missouri, 63017, United States
Unknown Facility
Mineola, New York, 11501, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Tyler, Texas, 75708, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 24626872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Steve Lamola, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2008
First Posted
December 9, 2008
Study Start
December 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
March 20, 2014
Results First Posted
March 20, 2014
Record last verified: 2014-02