Condition category
Respiratory
Date applied
29/01/2010
Date assigned
16/04/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tim Harrison

ORCID ID

Contact details

University of Nottingham
Respiratory Division
Clinical Sciences Building
Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 823 1725
tim.harrison@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33100; EME 08/246/02

Study information

Scientific title

Peroxisome proliferator-activated receptor gamma (PPAR-gamma): a novel therapeutic target for asthma? A randomised double-blind placebo-controlled clinical trial.

Acronym

Study hypothesis

To test the hypothesis that stimulation of peroxisome proliferator-activated receptor gamma (PPAR-gamma) receptors has a therapeutic role in the treatment of asthma.

Link to EME project website: http://www.eme.ac.uk/projectfiles/0824602info.pdf
Link to protocol: http://www.eme.ac.uk/projectfiles/0824602info.pdf

Ethics approval

Nottingham Research and Ethics Committee 2, 08/08/2008, ref: 08/H0408/120

Study design

Randomised double-blind placebo-controlled two parallel group clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

Participants are required for a total of 18 weeks. Follow up and investigation is identical in both arms. The run-in period is 2 weeks. Participants are randomised to either active or placebo arms for 12 weeks:
1. Pioglitazone 30 mg daily by mouth for 4 weeks then 45 mg daily for 8 weeks
2. Placebo 30 mg daily by mouth for 4 weeks then 45 mg daily for 8 weeks

The participants are followed up at weeks 4, 8 and 12. A final observation visit occurs at week 16 when the participants are no longer taking the IMP.

Intervention type

Drug

Phase

Not Applicable

Drug names

Pioglitazone

Primary outcome measures

FEV1 after 12 weeks

Secondary outcome measures

Change over 12 weeks in:
1. Daily asthma symptoms
2. Mean morning and evening peak flow
3. Juniper asthma control questionnaire and asthma quality of life scores
4. Exhaled nitric oxide level
5. Bronchial hyper-responsiveness
6. Induced sputum cell counts
7. Mechanistic analysis. This includes assay of histone acetyltransferase (HAT) and histone deacetylase (HDAC) levels, PPAR-gamma activation and measurement of chemokines (eotaxin, monocyte chemotactic protein-1 [MCP-1], IP10), growth factors (vascular endothelial growth factor [VEGF]) and effector mediators (cyst-leukotrienes, histamine and eosinophilic cationic protein).

Overall trial start date

01/01/2010

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 75 years, of either sex, with a clinical diagnosis of asthma
2. Forced expiratory volume in one second (FEV1) greater than or equal to 60% predicted and an increase in forced expiratory volume in one second (FEV1) of greater than 12% following inhaled salbutamol 400 µg or peak flow variability greater than 12% during run in
3. Permitted medication, 0 - 800 µg inhaled beclomethasone diproprionate or equivalent and a short acting beta-2-agonist as required

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Inability to produce a sputum sample on induction
2. Currently smoking
3. Greater than 10 pack years smoking history
4. Treatment with leukotriene antagonists
5. Long-acting beta agonists or theophylline
6. Liver or cardiovascular disease
7. Oral steroid treatment or exacerbation within 6 weeks
8. Females who are pregnant, lactating or not using adequate contraception
9. Any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepatic impairment, diabetic ketoacidosis)
10. Oral or insulin treatment for diabetes
11. Treatment with gemfibrozol or rifampicin

Recruitment start date

01/01/2010

Recruitment end date

01/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Paul Cartledge
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 951 5679
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/246/02)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nottingham Respiratory Biomedical Research Unit (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes