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Cystic Fibrosis | Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers

Cystic Fibrosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cystic Fibrosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Pioglitazone30 mg once a day

Drug:Simvastatin40 mg once a day

Drug:IbuprofenIbuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1-pioglitazonePioglitazone

2-simvasatinSimvastatin

3-Ibuprofen 1000-1600 mg/dayIbuprofen 1000-16-- mg/day, maximum 3200 mg/day

Study Status

Completed

Start Date: September 2007

Completed Date: February 2009

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Neutrophil Delivery to the Oral Mucosa Using a Non-invasive Mouthwash Technique

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Michael W Konstan, MD

Lead Sponsor: University Hospitals Cleveland Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00531882

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