NCT00634036

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Oct 2009

Typical duration for phase_2 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

July 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

March 5, 2008

Results QC Date

March 18, 2016

Last Update Submit

June 19, 2017

Conditions

Asthma

Keywords

Asthmaobesityexacerbationasthmaticsfatoverweightadipose tissueleptinadiponectinpioglitazoneActoswheezingPittsburghPennsylvaniapulmonarylung

Outcome Measures

Primary Outcomes (1)

  • Airway Reactivity

    Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by \> 20% from pre-methacholine baseline values.

    12 weeks

Secondary Outcomes (3)

  • FEV1 % Predicted

    12 weeks

  • Juniper Asthma Control Questionnaire

    12 weeks

  • Exhaled Nitric Oxide Ppb

    12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: pioglitazone

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

pioglitazoneDRUG

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

Also known as: Actos
1
placeboDRUG

matching placebo (inert tablet)

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asthma diagnosed by a physician at least 1 year prior to study enrollment
  • Poorly-controlled asthma at study enrollment
  • Non smokers (stopped smoking at least 1 year ago) and limited life-time history of smoking
  • Body mass index 30-60
  • Responds to methacholine challenge test with PC20 of \<16 mg/ml
  • On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry
  • FEV1 \>60% predicted
  • Able to obtain weekly weights at home

You may not qualify if:

  • Systemic steroids within the past 4 weeks
  • Lung pathology other than asthma
  • Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction \<50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine \>3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
  • B-type natriuretic peptide (BNP) \>400 pg/mL
  • Pregnant or lactating
  • Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD (thiazolidinedione), or allergic to TZD
  • Taking antioxidants or nutritional supplements (stable dose of calcium, vitamin D, or multivitamin is OK)
  • Illicit drug use within the past year
  • Current/active upper respiratory infection (if active URI, wait until asymptomatic for 1 week to enroll)
  • Asthma exacerbation within the past 4 weeks (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
  • Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months will be allowed to participate)
  • Clinically significant abnormalities present on screening 12-lead electrocardiogram
  • Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Vermont

Colchester, Vermont, 05446, United States

Location

Related Publications (3)

  • Hashimoto Y, Nakahara K. Improvement of asthma after administration of pioglitazone. Diabetes Care. 2002 Feb;25(2):401. doi: 10.2337/diacare.25.2.401. No abstract available.

    PMID: 11815521BACKGROUND

  • Lee KS, Kim SR, Park SJ, Park HS, Min KH, Jin SM, Lee MK, Kim UH, Lee YC. Peroxisome proliferator activated receptor-gamma modulates reactive oxygen species generation and activation of nuclear factor-kappaB and hypoxia-inducible factor 1alpha in allergic airway disease of mice. J Allergy Clin Immunol. 2006 Jul;118(1):120-7. doi: 10.1016/j.jaci.2006.03.021. Epub 2006 May 19.

    PMID: 16815147BACKGROUND

  • Dixon AE, Subramanian M, DeSarno M, Black K, Lane L, Holguin F. A pilot randomized controlled trial of pioglitazone for the treatment of poorly controlled asthma in obesity. Respir Res. 2015 Nov 26;16:143. doi: 10.1186/s12931-015-0303-6.

    PMID: 26610598DERIVED

Related Links

MeSH Terms

Conditions

AsthmaObesityPlatelet Glycoprotein IV DeficiencyOverweightRespiratory Sounds

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Fernando Holguin
Organization
University of Pittsburgh
holguinf@upmc.edu
412-692-2817

Study Officials

  • Fernando Holguin, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Anne E. Dixon, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 19, 2017

Results First Posted

July 19, 2017

Record last verified: 2017-06

Locations

US(2)