Status:
COMPLETED
Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be performed at the University of Washington. Forty subjects with Cystic Fibrosis will be enrolled, with 20 randomized into the usual care arm and 20 randomized into the intervention a...
Detailed Description
The study design is a single center, randomized non-blinded controlled clinical trial comparing usual care to a program of early identification and treatment of pulmonary exacerbation in adults with C...
Eligibility Criteria
Inclusion
- Male or female at least 18 years old
- Confirmed diagnosis of cystic fibrosis
- Chronically colonization wtih Pseudomonas defined by positive sputum or lower airway cultures on 2 or more occasions in any 12 month period
- Ability to participate in an interview and administration of questionnaire lasting 60 minutes
- Clinically stable without IV antibiotic treatment for a pulmonary exacerbation in the prior 2 weeks
- Ability to perform spirometry
- Have a home telephone line or home computer with internet connection
- Written informed consent
Exclusion
- Colonization with burkholderia cepacia complex
- Confirmed diagnosis of allergic bronchopulmonary aspergillosis as defined by the CFF guidance document
- Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium
- History of prior solid organ transplant
- Inability to speak and read the English language well enough to complete questionnaire
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00850551
Start Date
January 1 2009
End Date
December 1 2011
Last Update
December 1 2016
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195