- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00634036
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (GLITZ Asthma)
A Randomized, Placebo-Controlled Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or a placebo (an inactive pill). They will be given study medication to take everyday for 12 weeks (3 months).
Participants will complete a number of asthma-related questionnaires and a variety of pulmonary function tests. Participants will undergo physical exams, an electrocardiogram, and blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell counts, glucose levels, BNP hormone levels, and liver function.
To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12 weeks after starting study drug. At these visits many of the pulmonary function tests and questionnaires will be repeated.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh
-
-
Vermont
-
Colchester, Vermont, Forente stater, 05446
- University of Vermont
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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 <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
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 <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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: 2
|
matching placebo (inert tablet)
|
Aktiv komparator: 1
|
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Airway Reactivity
Tidsramme: 12 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
FEV1 % Predicted
Tidsramme: 12 weeks
|
12 weeks
|
|
Juniper Asthma Control Questionnaire
Tidsramme: 12 weeks
|
The Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control.
Values > 1.5 are compatible with poorly controlled asthma
|
12 weeks
|
Exhaled Nitric Oxide Ppb
Tidsramme: 12 weeks
|
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Fernando Holguin, MD, MPH, University of Pittsburgh
- Hovedetterforsker: Anne E. Dixon, MD, University of Vermont
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GLITZ 001
- 00001949
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