Smokers that are asthmatic
Conditions
Interventions
Trade Name: Avandia
Product Name: Rosiglitazone
Product Code: BRL-049653
Pharmaceutical Form: Tablet
INN or Proposed INN: Rosiglitazone
Current Sponsor code: BRL-049653
Concentration unit: mg milligra
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the effects of rosiglitazone against LD ICS on other endpoints of pulmonary function in smoking asthmatics To compare the effects of theophylline plus LD ICS against LD ICS on pulmonary function in smoking asthmatics To compare the effects of theophylline plus LD ICS against theophylline on pulmonary function in smoking asthmatics To assess the safety and tolerability of rosiglitazone, LD ICS, theophylline and theophylline plus LD ICS in smoking asthmatics To assess the effects in smoking asthmatics of rosiglitazone, LD ICS, theophylline 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. | — |
Countries
United Kingdom
Outcome results
None listed