Early Intervention in Cystic Fibrosis Exacerbation

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I'm Interested

Trial ID: NCT01104402

Age - 14 Years-N/A Condition - Pediatric Cystic Fibrosis, Pediatric Pulmonary Medicine Gender - All Accepting Healthy Volunteers - No

Purpose

Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.

Official Title

Early Intervention in Cystic Fibrosis Exacerbation

Eligibility


Inclusion Criteria:

   - CF diagnosis confirmed with sweat test, abnormal nasal potential difference and/or
   genetic testing

   - Age 14 and older

   - Able to perform spirometry

   - Clinically stable without antibiotic treatment for a pulmonary exacerbation in the two
   weeks prior to the screening visit

   - Forced expiratory volume in the first second (FEV1) greater than 25% of predicted at
   screening

Exclusion Criteria:

   - History of solid organ transplant

   - Participation in any interventional trial within the last 30 days

   - Inability to speak and read the English language well enough to complete
   questionnaires

   - Colonization with Burkholderia cepacia genomovar III within the last 24 months

   - Currently receiving antimicrobial treatment specifically used to treat active
   non-tuberculosis mycobacterium

   - Confirmed diagnosis of allergic bronchopulmonary aspergillosis (ABPA) as defined by
   the Cystic Fibrosis Foundation (CFF) guidance document that is being actively treated

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Intervention(s):

device: Home lung function and symptom monitoring

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Carlos Milla
650) 723-8325, (650) 736-9824

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