A 28-day, Randomised, Double-Blind, Active Comparator, Controlled Study to Assess the Effects of Rosiglitazone, Inhaled Corticosteroid, Theophylline and Theophylline Plus Inhaled Corticosteroid on Inflammation and Pulmonary function in Asthmatic Smokers.

GlaxoSmithKline Research & Development Limited0 sites88 target enrollmentStarted: May 6, 2005Last updated: May 1, 2012

Conditions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: GlaxoSmithKline Research & Development Limited
Enrollment: 88

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Male adults or female adults who are between 18 and 60 years of age (inclusive).
•2. Subjects with a clinical diagnosis of mild or moderate persistent asthma in
•accordance with the Global Initiative for Asthma (GINA) criteria.
•3. Have had a history of asthma for a minimum of 6 months prior to entry to the study.
•4. Subjects must be current cigarette smokers with a minimum five-pack-year smoking history (one pack-year equates to smoking 20 cigarettes daily for one year).
•5. Subjects must have a baseline FEV1 that is greater than 50% predicted and must
•demonstrate a reversibility of FEV1 after nebulized albuterol of 12% or more at
•screening, washout or randomisation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1. Asthma exacerbation or a respiratory tract infection within four weeks of screening.
•2. Subject has a history of Type 1 or Type 2 diabetes mellitus.
•3. Women who are lactating, pregnant, or planning to become pregnant.
•4. Presence of clinically significant renal or hepatic laboratory values (e.g.
•AST/ALT/total bilirubin/AP > 2.5 times normal values).
•5. Anaemia defined by haemoglobin concentration < 11 g/dL for males or < 10 g/dL for females.
•6. Subjects has any contraindications to treatment as outlined in any of the product
•7. The subject has a prior history of severe edema or a medically serious fluid related
•event (e.g., heart failure) associated with any TZD or PPAR? agonist.
•8. The subject has a history of significant hypersensitivity (e.g., difficulty swallowing,
•difficulty breathing, tachycardia or skin reaction) to TZDs.
•9. Presence of unstable or severe angina or congestive heart failure (NYHA class
•III/IV). Exclude subjects with evidence or history of known congestive heart failure
•(NYHA class I-IV), abnormal, clinically significant electrocardiogram (ECG) as
•determined by the Investigator or subjects who have had new cardiac events (such as MI, new CHF, PTCA, CABG) within 6 months of screening.
•10. Subjects with a history suggestive of active tuberculosis, lung cancer, sarcoidosis or clinically overt bronchiectasis.
•11. Subjects with any acute infection, severe sinus symptoms, or significant trauma
•(burns, fractures).
•12. Subjects with clinically significant renal disease, metabolic syndrome, cirrhosis
•(Child-Pugh Class B/C), hypertension or any other clinically significant
•cardiovascular, neurological, endocrine, or haematological abnormalities that are
•uncontrolled on permitted therapy.
•13. Subjects with risk factors for human immunodeficiency virus (HIV), Hepatitis B or
•Hepatitis C infection at Screening (Visit 1).
•14. Subjects who are morbidly obese, defined as having a body mass index (BMI) > 40 kg/m2.
•15. Subjects who have undergone recent surgery or have conditions that prevent them from performing spirometry.
•16. Subjects who require treatment with any of the following asthma medications from the Screening (Visit 1) until study completion:
•Inhaled cromolyn sodium or nedocromil
•Ipratropium bromide
•Xanthines (theophylline preparations).
•Leukotriene modifiers
•Long-acting inhaled beta2-agonists (salmeterol, formoterol)
•Oral beta2-agonists
•17. Subjects who have received treatment with oral, intravenous or intra-articular
•corticosteroids within 6 weeks of Screening or thereafter.
•18. Subjects who have been taking in excess of 1000 µg daily of beclomethasone or
•equivalent within 6 weeks of screening.

Investigators

Sponsor

GlaxoSmithKline Research & Development Limited

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