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Pioglitazone Hydrochloride (Actos(Registered Trademark)) to Treat Asthma

NCT00604578 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will test whether pioglitazone hydrochloride (Actos (Registered Trademark) Registered Trademark) is effective for treating patients with asthma who do not respond to standard therapy. Experiments have shown that this drug, which is used to treat patients with diabetes, may be effective for treating asthma.

People between 18 and 75 years of age who have had asthma for at least a1 year and whose symptoms are not well controlled with high doses of inhaled corticosteroids with or without long-acting bronchodilators may be eligible for this study. Candidates are screened with breathing tests, an allergy skin test, chest x-ray, electrocardiogram (ECG), echocardiogram (ultrasound test of the heart), blood tests, and DEXA scan (an x-ray to measure bone thickness) to make sure they are eligible for the study.

Then, participants undergo tests and procedures in the following study phases:

Phase 1

Participants are given a device to measure and record their lung function and asthma symptoms at home each morning and night for 4 weeks before starting the study medication. Lung function is also measured at clinic visits before and after inhaling a bronchodilator medicine. Before starting the study medication, participants have a sputum induction (sputum collection test). For this test, the participants inhale a salt-water mist and are asked to collect sputum into a plastic cup.

Phase II

Participants are randomly selected to receive either pioglitazone hydrochloride or placebo (a look-alike pill with no active ingredient) once a day for 10 weeks. They return to the clinic after 2 weeks to repeat the tests done in Phase 1 and to monitor any reactions to the study drug or placebo. If there are no problems, the amount of medication is increased once, and then they return for follow-up evaluations every 2 weeks for 8 weeks. Pulmonary function tests, sputum collection and DEXA scan are repeated after 10 weeks on medication.

Phase III

Patients return for follow-up 1 month after stopping the medication or placebo to monitor their asthma.

...

Conditions

  • Asthma
  • Airway Inflammation
  • Airflow Obstruction
  • Airway Hyperactivity

Interventions

DRUG

Pioglitazone Hydrochloride

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-04
Primary Completion
2009-10-30
Completion
2009-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00604578 on ClinicalTrials.gov