EUCTR2004-004247-22-GB进行中（未招募）不适用
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.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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