Trial Outcomes & Findings for Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers (NCT NCT00531882)
NCT ID: NCT00531882
Last Updated: 2017-10-05
Results Overview
Oral mucosal polymorphonuclear leukocytes (PMN) are obtained and assessed using a modification of the mouthwash method of (Wright et.al. Blood 1986;67:1023-30). For each subject, PMN counts are assessed on days 1, 2, 3 \[Baseline (B)\]; days 8, 9, 10 \[Treatment (T)\]; and days 11, 13, 15 \[Recovery (R)\]. The PMN counts for each subject are averaged for each study time period (B, T or R) within each study arm (Pioglitazone, Simvastatin and Ibuprofen). The mean baseline (B) PMN counts are compared to the mean treatment (T) PMN counts for each study arm, with the results expressed as the percent change in PMN counts . Paired T-tests between baseline and treatment PMN counts are used to analyze for significance. The recovery period is used to verify that the PMN counts return to baseline following the treatment period. Data from the recovery period is not shown.
COMPLETED
NA
25 participants
3X Before treatment (Days 1,2,3) 3X During treatment (Days 8,9,10)
2017-10-05
Participant Flow
Subjects were recruited from lab personnel and CF Center employees and UH employees and by word of mouth. Due to the vulnerability of this population every effort was made to avoid coercion. No one was enrolled that was directly supervised by the PI. The recruitment log was kept in a secure location in the CF Team Office.
Inclusion and exclusion criteria were reviewed at screening. Concomitant medications were reviewed prior to randomization. Subjects were excluded if they were on NSAIDS, corticosteroids (including inhaled steroids and statin lowering medications.
Participant milestones
| Measure |
1-Pioglitazone
Pioglitazone
Pioglitazone: 30 mg once a day pioglitazone (Actos, Takeda) will be administered orally in a dose of 30 mg once daily. This is the highest recommended dose for initial control of type II diabetes.
|
2-Simvastatin
Simvastatin (Zocor): 40 mg once a day will be administered orally in a dose of 49 mg once daily to all subjects. This dose is considered a mid-level adult dose and the maximum pediatric dose recommended for hyperlipidemia.
|
3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)
Ibuprofen will be used as the positive control for this study. Ibuprofen (Motrin, Pharmacia) will be administered twice daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
1-Pioglitazone
n=10 Participants
Pioglitazone
Pioglitazone: 30 mg once a day
|
2-Simvastin
n=10 Participants
Simvastatin
Simvastatin: 40 mg once a day
|
3-Ibuprofen 1000-1600 mg Twice Daily
n=5 Participants
Ibuprofen 1000-1600 mg twice daily (max 3200 mg/day)
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
28.8 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
24.5 years
STANDARD_DEVIATION 4.0 • n=27 Participants
|
27.6 years
STANDARD_DEVIATION 2.8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 3X Before treatment (Days 1,2,3) 3X During treatment (Days 8,9,10)Population: Healthy volunteers free of gingival disease were randomized 2:2:1 to oral Pioglitazone, Simvastatin or Ibuprofen respectively for 10 days.
Oral mucosal polymorphonuclear leukocytes (PMN) are obtained and assessed using a modification of the mouthwash method of (Wright et.al. Blood 1986;67:1023-30). For each subject, PMN counts are assessed on days 1, 2, 3 \[Baseline (B)\]; days 8, 9, 10 \[Treatment (T)\]; and days 11, 13, 15 \[Recovery (R)\]. The PMN counts for each subject are averaged for each study time period (B, T or R) within each study arm (Pioglitazone, Simvastatin and Ibuprofen). The mean baseline (B) PMN counts are compared to the mean treatment (T) PMN counts for each study arm, with the results expressed as the percent change in PMN counts . Paired T-tests between baseline and treatment PMN counts are used to analyze for significance. The recovery period is used to verify that the PMN counts return to baseline following the treatment period. Data from the recovery period is not shown.
Outcome measures
| Measure |
1-Pioglitazone
n=10 Participants
Pioglitazone
Pioglitazone: 30 mg once a day
|
2-Simvastatin
n=10 Participants
Simvastatin
Simvastatin: 40 mg once a day
|
3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)
n=5 Participants
Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
|
|---|---|---|---|
|
Neutrophil Delivery to the Oral Mucosa Using a Non-invasive Mouthwash Technique
|
6.4 % change in mean PMN counts: B vs T
|
-19.6 % change in mean PMN counts: B vs T
|
-28.4 % change in mean PMN counts: B vs T
|
Adverse Events
1-Pioglitazone
2-Simvastin
3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1-Pioglitazone
n=10 participants at risk
Pioglitazone
Pioglitazone: 30 mg once a day
|
2-Simvastin
n=10 participants at risk
Simvastatin
Simvastatin: 40 mg once a day
|
3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)
n=5 participants at risk
Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
joint pain
|
0.00%
0/10 • Subjects were questioned and examined by the Investigator or his/her designee for evidence of adverse events. Subjects were monitored for the 15 days they participated in the study.
|
20.0%
2/10 • Number of events 2 • Subjects were questioned and examined by the Investigator or his/her designee for evidence of adverse events. Subjects were monitored for the 15 days they participated in the study.
|
0.00%
0/5 • Subjects were questioned and examined by the Investigator or his/her designee for evidence of adverse events. Subjects were monitored for the 15 days they participated in the study.
|
Additional Information
Michael W Konstan, MD
University Hospitals Case Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place