Phase 2
N=23
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00634036 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Airway Reactivity — 5.08; 2.37 mg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pioglitazone (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fernando Holguin
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Reactivity |
5.08; 2.37 | — |
| SECONDARY FEV1 % Predicted |
80.3; 85.2 | — |
| SECONDARY Juniper Asthma Control Questionnaire |
1.62; 1.82 | — |
| SECONDARY Exhaled Nitric Oxide Ppb |
27.6; 30.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 60% predicted
- Able to obtain weekly weights at home
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00634036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.