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| Sponsor: | University Hospitals of Cleveland |
|---|---|
| Information provided by: | University Hospitals of Cleveland |
| ClinicalTrials.gov Identifier: | NCT00531882 |
Purpose
Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease, and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of decline of pulmonary function. However, utilization of this valuable drug has been suboptimal because of its rare, but dramatic, adverse effects. Therefore, alternative anti-inflammatory agents are urgently needed. One strategy for identifying new anti-inflammatory agents is to determine the mechanism by which the only proven anti-inflammatory agent for the CF lung disease, high-dose ibuprofen, exerts its effect. If this were known, then other drugs that act by a similar mechanism become candidates for treating the CF inflammatory disease. The investigators have shown, in our preliminary studies, that high dose ibuprofen limits the delivery of neutrophils to an inflamed mucosal surface, the gingival crevices. The investigators plan to test pioglitazone and simvastatin, (ibuprofen (positive control)) to determine their anti inflammatory affects on neutrophil migration to the oral mucosa.
The hypothesis to be tested is that pioglitazone, and/or simvastatin will reduce neutrophils in the oral mucosa after 10 days of therapy in mouthwashes of healthy volunteers. Ibuprofen will be used as a positive control.
This study will provide pilot data from healthy volunteers to support an FDA Grant to be submitted at a future date.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis Anti Inflammatory Non-Steroidal Neutrophils |
Drug: Pioglitazone Drug: Simvastatin Drug: Ibuprofen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Pilot Study Evaluating the Effect of Pioglitazone, Simvastatin, and Ibuprofen on Neutrophil Migration in Vivo in Healthy Subjects |
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Pioglitazone
|
Drug: Pioglitazone
30 mg once a day
Other Name: ACTOS
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Experimental: 2
Simvastatin
|
Drug: Simvastatin
40 mg once a day
Other Name: Zocor
|
|
Active Comparator: 3
Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
|
Drug: Ibuprofen
Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
Other Name: Motrin
|
The entire study period for each subject will be 15 days, and consist of 3 periods defined as: Baseline (Day 1,2,3), Treatment (Day 3-10), and Recovery (Day 13-15). Healthy volunteers will be screened on Day 1 (and assessed for eligibility); Eligible subjects will be divided into 3 drug treatment groups pioglitazone, simvastatin and ibuprofen the positive control. The two treatment groups will consist of 4 healthy volunteers who meet the inclusion criteria. There will be 2 healthy volunteers in the positive control group. Group 1 will receive pioglitazone 30 mg once daily, Group 2 will receive simvastatin 40 mg daily and Group 3 the positive control will receive ibuprofen (15-23 mg/kg twice daily, maximum 3200 mg/day) during the Treatment period and serve as the positive control group. This dose is 25% of that prescribed to CF patients. As healthy volunteers are recruited, the first will be assigned to Group 1, the second to Group 2, and so on. After the third subject has been assigned to Group 3, this pattern of assignment will be repeated with subjects 4, 5 and 6, The following 4 healthy volunteers will be assigned to group 1 and 2 (7, 8, 9, 10).
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathleen A Hilliard, BA, CCRC | 216.844.7489 | kathleen.hilliard@case.edu |
| Contact: Colette Bucur, CNP | 216.844.1902 | colette.bucur@case.edu |
| United States, Ohio | |
| University Hospitals of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kathleen A Hilliard, BA, CCRC 216-844-7489 kathleen.hilliard@case.edu | |
| Contact: Colette Bucur, CNP 216.844.1902 colette.bucur@case.edu | |
| Principal Investigator: Michael W Konstan, MD | |
| Principal Investigator: | Michael W Konstan, MD | University Hospitals of Cleveland |
More Information
| Responsible Party: | Kate Hilliard, BA, CCRC, Rainbow Babies and Children's Hospital-CF Center |
| ClinicalTrials.gov Identifier: | NCT00531882 History of Changes |
| Other Study ID Numbers: | Pilot Healthy Volunteers |
| Study First Received: | September 18, 2007 |
| Last Updated: | August 15, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
healthy volunteers neutrophil migration anti inflammatory non-steroidal agent simvastatin pioglitazone |
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Ibuprofen Simvastatin Pioglitazone Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Hypoglycemic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |
