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Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiectasis

Intervention: AZLI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Steve Lamola, MD, Study Director, Affiliation: Gilead Sciences

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.

Clinical Details

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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)

Convergent Validity of the Respiratory Domain of the 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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Birmingham, Alabama 35209, United States

Peoria, Arizona 85381, United States

Phoenix, Arizona 85006, United States

Orange, California 92868, United States

Denver, Colorado 80206, United States

Farmington, Connecticut 06030, United States

New Haven, Connecticut 06519, United States

Washington, District of Columbia 20007, United States

Miami, Florida 33136, United States

Atlanta, Georgia 30342, United States

Marietta, Georgia 30060, United States

Chicago, Illinois 60637, United States

Olathe, Kansas 66061, United States

Boston, Massachusetts 02118, United States

Chesterfield, Missouri 63017, United States

Mineola, New York 11501, United States

New York, New York 10032, United States

Chapel Hill, North Carolina 27599, United States

Portland, Oregon 97239, United States

Philadelphia, Pennsylvania 19104, United States

Charleston, South Carolina 29425, United States

Tyler, Texas 75708, United States

Charlottesville, Virginia 22908, United States

Madison, Wisconsin 53792, United States

Additional Information

Starting date: December 2008
Last updated: February 3, 2014

Page last updated: August 20, 2015

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