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Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
Information provided by:
University Hospitals Cleveland Medical Center Identifier:
First received: September 18, 2007
Last updated: August 15, 2008
Last verified: August 2008
September 18, 2007
August 15, 2008
September 2007
February 2009   (Final data collection date for primary outcome measure)
Neutrophil delivery to the oral mucosa using a noninvasive mouth wash technique [ Time Frame: 3x before treatment, 3x during treatment and 3x post treatment ]
Same as current
Complete list of historical versions of study NCT00531882 on Archive Site
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Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
A Pilot Study Evaluating the Effect of Pioglitazone, Simvastatin, and Ibuprofen on Neutrophil Migration in Vivo in Healthy Subjects

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.

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).
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Cystic Fibrosis
  • Anti Inflammatory Non-Steroidal
  • Neutrophils
  • Drug: Pioglitazone
    30 mg once a day
    Other Name: ACTOS
  • Drug: Simvastatin
    40 mg once a day
    Other Name: Zocor
  • Drug: Ibuprofen
    Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
    Other Name: Motrin
  • Experimental: 1
    Intervention: Drug: Pioglitazone
  • Experimental: 2
    Intervention: Drug: Simvastatin
  • Active Comparator: 3
    Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
    Intervention: Drug: Ibuprofen
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Pilot Healthy Volunteers
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Kate Hilliard, BA, CCRC, Rainbow Babies and Children's Hospital-CF Center
University Hospitals Cleveland Medical Center
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Principal Investigator: Michael W Konstan, MD University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP