Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
Recruitment status was Recruiting
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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 |
- Neutrophil delivery to the oral mucosa using a noninvasive mouth wash technique [ Time Frame: 3x before treatment, 3x during treatment and 3x post treatment ] [ Designated as safety issue: No ]
| 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
|
|
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
|
Detailed Description:
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:
- ≥ 18 < 50 years of age
- Healthy volunteers must be in general good health as determined by a medical history.
- Ability to understand and sign the informed consent form
- Ability to adhere to the protocol.
- Willing to use an acceptable form of birth control
Exclusion Criteria:
- History of diabetes requiring insulin
- The use of NSAIDS (ibuprofen) or corticosteroids including inhaled steroids. Nasal steroids are acceptable.
- The use of statin lowering medications
- Active gingival disease (Active tooth or gum disease)
- Any chronic inflammatory condition that immuno compromises the volunteer as determined by medical history.
- Pregnant or planning to become pregnant
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
No publications provided
| 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 |
Keywords provided by University Hospitals of Cleveland:
|
healthy volunteers neutrophil migration anti inflammatory non-steroidal agent simvastatin pioglitazone |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 18, 2013