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| Sponsor: | FDA Office of Orphan Products Development |
|---|---|
| Collaborator: |
Case Western Reserve University |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004440 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis |
Drug: ibuprofen |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label |
| Estimated Enrollment: | 75 |
| Study Start Date: | August 1996 |
| Estimated Study Completion Date: | June 1999 |
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| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
| Study ID Numbers: | 199/13438, CWRU-FDR001185 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004440 History of Changes |
| Health Authority: | United States: Federal Government |
|
cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease |
|
Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Fibrosis Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Digestive System Diseases Pathologic Processes Cystic Fibrosis Respiratory Tract Diseases |
Genetic Diseases, Inborn Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |
