Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: ibuprofen (Drug)
Phase: N/A
Status: Completed
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Michael W Konstan, Study Chair, Affiliation: Case Western Reserve University
Summary
OBJECTIVES:
I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear
leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic
fibrosis and healthy controls.
II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN
delivery to a mucosal surface in these patients.
Clinical Details
Study design: Treatment, Randomized, Open Label
Detailed description:
PROTOCOL OUTLINE:
This is an open label study. Patients are randomized into 5 arms, each consisting of 10
healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen
received during the treatment period.
The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3),
treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period
patients receive ibuprofen orally every 12 hours (except for a control arm that receives no
ibuprofen).
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
Confirmed diagnosis of cystic fibrosis (CF) based on: Sweat chloride greater than 60 mEq/L
AND Typical pulmonary and/or gastrointestinal manifestation of CF OR Healthy volunteers
- -Prior/Concurrent Therapy--
At least 30 days since medications with anti-neutrophil or anti-inflammatory effect (e. g.,
aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], corticosteroids, macrolide
antibiotics)
- -Patient Characteristics--
Age: Patients with cystic fibrosis (CF): 5 and over; Healthy volunteers: 18 and over
Hematopoietic: No significant history of hematologic disease
Hepatic: No significant history of hepatic disease
Renal: No significant history of renal disease
Cardiovascular: No significant history of cardiovascular disease
Pulmonary: See Disease Characteristics
Neurologic: No significant history of neurologic disease
Other: Not pregnant; No significant history of peptic ulcer disease; Patients with CF free
of any acute illness within 14 days; No prior hypersensitivity to any NSAID
Locations and Contacts
Additional Information
Starting date: August 1996
Ending date: June 1999
Last updated: June 23, 2005
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