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AsthmaPhase 2NCT00604578

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

A Phase 2 study testing Pioglitazone Hydrochloride in people with Asthma and Airway Inflammation, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma, Airway Inflammation, Airflow Obstruction
What is being tested?
Pioglitazone Hydrochloride
How many people
0 participants
Where
2 sitesUnited States
Study dates
4 Jan 2008to 30 Oct 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be between 18 and 75 years of age, male or female, with a diagnosis of asthma for at least one year.
  • Patients must have reversible airflow obstruction as defined by a positive methacholine bronchoprovocation challenge or a positive response to inhaled bronchodilators.
  • Patients must be treated with EPR-3 Step 5 therapy (high dose (great than or equal to 440 ucg/day) fluticasone inhaler or equivalent dose of another inhaled corticosteroid) with or without an inhaled long-acting beta-2-agonist) for at least 3 months.
  • Patients must meet the EPR-3 criteria for not well controlled asthma. The EPR-3 definition for not well controlled asthma includes any of the following features in a week (unless otherwise indicated): daytime asthma symptoms great than 2 days/week, limitation of activities, nocturnal symptoms or awakening greater than 2 times/month, need for reliever/rescue treatment greater than 2 days/week, PEF or FEV(1) less than 80% predicted.
  • Pre-bronchodilator FEV(1) greater than or equal to 55% of predicted and post-bronchodilator FEV(1) greater than or equal to 60% of predicted.
  • During the 6 weeks prior to enrollment, patients should have stable asthma as defined by the absence of unscheduled health care visits for asthma care and unchanged use of asthma maintenance therapy. Additional criteria for disease stability include the absence of hospitalization for asthma or the need for a course of oral corticosteroids during the preceding 3 months.
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  • Research subjects must have a positive skin test to a common aeroallergen, such as dust mite, cat, short ragweed, cockroach, or grass or a prior history of severe allergy or anaphylaxis.
  • Chest radiograph without evidence of pulmonary disease, other than asthma.
  • Left ventricular ejection fraction greater than or equal to 50% by echocardiogram.
  • For women of childbearing potential, negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study.
  • Subjects with a history of dermatologic cancers may be included if they have been cancer-free for at least 5 years prior to enrollment.

Who cannot join

  • A known history of hypersensitivity to pioglitazone.
  • Maintenance asthma therapy with oral corticosteroids, xolair (anti-IgE), methotrexate, cytoxan, gold salts, or cyclosporine.
  • Cigarette smoking within the past 3 months or a prior history of greater than 10 cumulative pack-years.
  • Viral or bacterial upper respiratory tract infection within 6 weeks prior to the screening visit.
  • Investigational therapy for any indication within 1 month prior to the screening visit.
  • History of lung disease other than asthma (i.e., COPD, sarcoidosis).
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  • History of diabetes mellitus, insulin secreting tumor, or symptomatic hypoglycemia.
  • HIV or other known immunodeficiency.
  • History of congestive heart failure.
  • Preexisting edema (2 plus or greater).
  • Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.
  • History of liver disease or abnormal liver function tests greater than 2 times upper limit of normal.
  • History of inflammatory bowel disease.
  • History of cancer (other than dermatologic cancer).
  • History of drug or alcohol abuse.
  • Use of the following medications, which can interact with pioglitazone:
  • Gemfibrizol (Lopid)
  • Atazanivir (Reyataz)
  • Ritonavir (Norvir)
  • Rifampin (Rifampicin)
  • Carbamzepine (Tegretol)
  • Phenobarbital (Luminal)
  • Phenytoin (Dilantin)
  • Rifapentine (Priftin)
  • Secobarbital (Seconal)
  • Amiodarone (Cordarone, Pacerone)
  • Palitaxel (Taxol)
  • Replaglinide (Prandine)
  • Ketoconazole (Nizoral)
  • Atorvastatin (Lipitor(Registered Trademark))
  • Nifedipine ER (Adalat CC)
  • Any condition that, in the investigator's opinion, places the patient at undue risk for complications from pioglitazone therapy.
  • Dexa bone scan (T score below -1 SD).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

  • Fairfax Hospital

    Falls Church, Virginia, 22046

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Allergic Asthma

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.

Read more

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.

...

Read the detailed description

New therapies are needed for patients with asthma who are suboptimally controlled by standard measures. Pioglitazone hydrochloride (Actos [R]) is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPAR gamma). Studies in murine models of allergic asthma have shown that PPAR gamma-agonists down-regulate allergen-mediated airway inflammation and airway hyperresponsiveness. This protocol is a randomized, placebo-controlled, double-blind, parallel-group (phase II) pilot study of the efficacy and safety of pioglitazone for the treatment of patients with allergic asthma and reversible airflow obstruction who are persistently symptomatic despite therapy with high doses of inhaled corticosteroids with or without long-acting Beta 2-agonists. The primary end-point for this study will be the change in airflow obstruction, as measured by the post-bronchodilator FEV1. Secondary end-points will include indices of airway inflammation, airflow obstruction, airway hyperreactivity, and asthma symptoms.

Being tested
Pioglitazone Hydrochloride
Keywords
Pioglitazone, Asthma, Peroxisome Proliferator-Advanced Receptor Gamma, Airflow Obstruction, Airway Inflammation
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pioglitazone HydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in post-bronchodilator FEV1.

    Measured: 10 weeks

Secondary outcomes (1)

  1. Airway inflammation, Airflow Obstruction, Airway Hyperreactivity, Asthma Symptoms, Rate of mild exacerbation, Rate of severe exacerbation, Asthma Quality-of-life, Blood Eosinophil Counts, Serum IgE and Exhaled Nitric Oxide Levels.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study start4 Jan 2008
  3. Primary completion30 Oct 2009 (estimated)
  4. Study completion30 Oct 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604578
Sponsor's protocol ID
080047
Other IDs
08-H-0047
Status last verified
30 Oct 2009
First submitted
8 Jan 2008
Last updated
2 Jul 2017
Results posted
No

Publications

  • Wenzel SE. Asthma: defining of the persistent adult phenotypes. Lancet. 2006 Aug 26;368(9537):804-13. doi: 10.1016/S0140-6736(06)69290-8.

    PubMed 16935691

  • Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.

    PubMed 16236742

  • Strunk RC, Bloomberg GR. Omalizumab for asthma. N Engl J Med. 2006 Jun 22;354(25):2689-95. doi: 10.1056/NEJMct055184. No abstract available.

    PubMed 16790701

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone Hydrochloride in people with Asthma and Airway Inflammation, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in post-bronchodilator FEV1. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604578, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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