Trial Outcomes & Findings for The Use of Rosiglitazone to Treat Asthma (NCT NCT00614874)

NCT ID: NCT00614874

Last Updated: 2011-09-02

Results Overview

PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: patients were assessed at baseline and at 12 weeks
• Results posted on: 2011-09-02

Participant Flow

Recruitment was through pulmonary and allergy/immunology clinics from September 2008 to November 2009.

32 patients assessed for eligibility. 16 did not meet inclusion criteria. None of the 16 participants allocated to treatment were excluded before the study began.

Participant milestones

Measure	Rosiglitazone Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Rosiglitazone Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The Use of Rosiglitazone to Treat Asthma

Baseline characteristics by cohort

Measure	Rosiglitazone n=16 Participants Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	34 years STANDARD_DEVIATION 24 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: patients were assessed at baseline and at 12 weeks

Population: 3 subjects were not included in the final analysis due to missing data. Two subjects withdrew by visit 3. 1 had missing data at visit 2 due to equipment failure.

PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%

Outcome measures

Measure	Rosiglitazone n=13 Participants Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Methacholine Responsiveness as Assessed by PC20, Baseline	3.27 mg/mL Standard Deviation 2.34
Methacholine Responsiveness as Assessed by PC20, Week 12	8.71 mg/mL Standard Deviation 7.77

SECONDARY outcome

Timeframe: patients were assessed at baseline and 12 weeks

Population: 2 patients withdrew from the study in visit 3

Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.

Outcome measures

Measure	Rosiglitazone n=14 Participants Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion Baseline	48 parts per billion Standard Deviation 32
Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion 12 weeks	41 parts per billion Standard Deviation 35

SECONDARY outcome

Timeframe: patients were assessed at baseline and 12 weeks

Population: Two subjects withdrew from the study in visit 3

FEV1 in liters

Outcome measures

Measure	Rosiglitazone n=14 Participants Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Forced Expiratory Volume in 1 Second (FEV1) Baseline	2.95 Liters Standard Deviation 0.89
Forced Expiratory Volume in 1 Second (FEV1) Week 12	3.04 Liters Standard Deviation 0.95

SECONDARY outcome

Timeframe: patients were assessed at baseline and 12 weeks

Population: Two subjects withdrew from the study in visit 3

Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.

Outcome measures

Measure	Rosiglitazone n=14 Participants Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Forced Expiratory Volume in One Second (FEV1) Percent Predicted Baseline	82 percent predicted Standard Deviation 12
Forced Expiratory Volume in One Second (FEV1) Percent Predicted Week 12	85 percent predicted Standard Deviation 15

Adverse Events

Rosiglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tammy Wichman

Creighton University School of Medicine

Phone: 402-449-4486

Email: wichman@creighton.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place