Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis
Completed · Not applicable
Conditions studied: Cystic Fibrosis
In brief
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 arm. All subjects will be enrolled for 6 months and have 3 study visits. One at baseline, midpoint, and final. The intervention arm subjects may have more study visits depending on their respiratory symptoms. The intervention arm subjects will perform home spirometry twice a week with a PiKo-6 hand held spirometer. They will also have a home-based telemonitoring system connected to their phone line. They will be prompted twice a week to answer questions regarding their health via the telemonitor. Subjects who are not able to utilize the home-based telemonitoring system will answer the questions regarding their health via the internet from their home computer. If the subject's spirometry falls by greater than 10% from baseline or the CF respiratory symptoms change in 3 or more of the 8 respiratory symptoms captured by the telemonitor questionnaire, the subject will be called by the research staff and clinically evaluated by the study PIs within three days. The usual care subjects will continue with their routine care at the University of Washington CF Clinic.
Key facts
- Study ID
- NCT00850551
- Run by
- University of Washington
- People needed
- 42
- Starts
- 2009-01-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2016-12-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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