- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805025
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35209
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Arizona
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85006
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California
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Orange, California, United States, 92868
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Colorado
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Denver, Colorado, United States, 80206
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Connecticut
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Farmington, Connecticut, United States, 06030
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New Haven, Connecticut, United States, 06519
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District of Columbia
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Washington, District of Columbia, United States, 20007
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Florida
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Miami, Florida, United States, 33136
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Georgia
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Atlanta, Georgia, United States, 30342
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Marietta, Georgia, United States, 30060
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Illinois
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Chicago, Illinois, United States, 60637
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Kansas
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Olathe, Kansas, United States, 66061
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Massachusetts
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Boston, Massachusetts, United States, 02118
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Missouri
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Chesterfield, Missouri, United States, 63017
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New York
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Mineola, New York, United States, 11501
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New York, New York, United States, 10032
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Oregon
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Portland, Oregon, United States, 97239
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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South Carolina
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Charleston, South Carolina, United States, 29425
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Texas
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Tyler, Texas, United States, 75708
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Virginia
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Charlottesville, Virginia, United States, 22908
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Wisconsin
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Madison, Wisconsin, United States, 53792
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: AZLI
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.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)
Time Frame: Day -14 to Day 0
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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
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Convergent Validity of the Respiratory Domain of the QOL-B
Time Frame: Day -14
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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.
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Day -14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
Time Frame: Day 0 to Day 28
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The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change: If the corresponding GRCQ score was in the "no change" group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score. Then the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID. |
Day 0 to Day 28
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steve Lamola, MD, Gilead Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-219-0102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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