Asthma Respiratory Asthma
Conditions
Interventions
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
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
United Kingdom
Outcome results
None listed