Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis
NCT ID: NCT00805025
Last Updated: 2014-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2008-12-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
AZLI
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
Interventions
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AZLI
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Steve Lamola, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Birmingham, Alabama, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Orange, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Olathe, Kansas, United States
Boston, Massachusetts, United States
Chesterfield, Missouri, United States
Mineola, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Tyler, Texas, United States
Charlottesville, Virginia, United States
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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GS-US-219-0102
Identifier Type: -
Identifier Source: org_study_id
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