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.

• Conditions: Smokers that are asthmatic

• Registration Number: EUCTR2004-004247-22-GB
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-06
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

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
labels.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To compare the effects of rosiglitazone against LD ICS on other endpoints of pulmonary function in smoking asthmatics<br><br>To compare the effects of theophylline plus LD ICS against LD ICS on pulmonary<br>function in smoking asthmatics<br><br>To compare the effects of theophylline plus LD ICS against theophylline on<br>pulmonary function in smoking asthmatics<br><br>To assess the safety and tolerability of rosiglitazone, LD ICS, theophylline and<br>theophylline plus LD ICS in smoking asthmatics<br><br>To assess the effects in smoking asthmatics of rosiglitazone, LD ICS, theophylline<br>and theophylline plus LD ICS on asthma control using the Asthma Control Questionnaire (ACQ);Main Objective: Comparison of pre-bronchodilator (FEV1) at 28 days between rosiglitazone and Low Dose Inhaled Corticosteroid (LD ICS) treatment groups;Primary end point(s): Pre-bronchodilator FEV1 at 28 days.