Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University Hospitals of Cleveland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00531882
First received: September 18, 2007
Last updated: August 15, 2008
Last verified: August 2008
  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

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531882

Contacts
Contact: Kathleen A Hilliard, BA, CCRC 216.844.7489 kathleen.hilliard@case.edu
Contact: Colette Bucur, CNP 216.844.1902 colette.bucur@case.edu

Locations
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         
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
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 April 17, 2014