Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics

NCT00634036 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-07-19

Study results available
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Summary

Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.

Researchers believe this occurs because excess adipose tissue (fat) in the body can cause higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood.

The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.

Conditions

Interventions

DRUG

pioglitazone

pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)

DRUG

placebo

matching placebo (inert tablet)

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY
  • University of Vermont

    collaborator OTHER
  • Fernando Holguin

    lead OTHER

Principal Investigators

  • Fernando Holguin, MD, MPH · University of Pittsburgh

  • Anne E. Dixon, MD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634036 on ClinicalTrials.gov