A 16-week randomised, placebo-controlled, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of tiotropium inhalation solution delivered by the Respimat® inhaler (2 puffs of 2.5 µg once daily) with that of salmeterol from the hydrofluoroalkane metered dose inhaler (2 puffs of 25 µg twice daily) in moderate persistent asthma patients homozygous for B16-Arg/Arg. - Tiotropium Salmeterol Study
- Conditions
- Patients with moderate persistent bronchial asthma and homozygous for arginine at the 16th position of the beta-2-adrenergic receptorMedDRA version: 9.0Level: LLTClassification code 10003555
- Registration Number
- EUCTR2005-005616-25-AT
- Lead Sponsor
- Boehringer Ingelheim Austria GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 474
1. Patients must be homozygous for arginine at the 16th amino acid position of the ß2 adrenergic receptor (B16 Arg/Arg)
2. All patients must sign and date an Informed Consent form for the study consistent with ICH-GCP guidelines and local legislation prior to any study related procedures which includes medication washout and restrictions
3. Male or female outpatients between 18 and 60 years
4. Patients must have a documented history of asthma and must be current non-smokers or ex-smokers with no more than 10 pack years
5. All patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent within the last 3 months and with a stable dose within the last 3 weeks
6. Two groups of patients are eligible for this study depending on their LABA pre-treatment:
• Patients who are on a maintenance treatment with LABAs with a total daily dose of at least 100 µg salmeterol or at least 18 µg formoterol within the last 3 months and a stable dose within the last 3 weeks are eligible if they meet the following spirometric criterion:
Pre-bronchodilator FEV1 <=90% of predicted normal
• Patients who have not been treated with LABAs within the last year before visit 1 are eligible if they meet the following spirometric criterion:
Pre-bronchodilator FEV1 <=80% of predicted normal at visit 1
7. Patients must demonstrate an increase in FEV1 of at least 12% and 200mL 45 minutes after 80 mcg ipratropium bromide administration or 30 minutes after subsequently administered 400mcg salbutamol
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
1. Patients with a significant disease other than asthma; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study.
2. Patients with a recent history (i.e., six months or less) of myocardial infarction
3. Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year
4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
8. Patients with known active tuberculosis
9. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
10. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.
11. Patients who are being treated with beta-blocker medication. Cardio-selective beta-blocker eye medication for treatment of non-narrow angle glaucoma are allowed.
12. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within 4 weeks prior to visit 1
13. Patients who were treated with cromolyn sodium or nedocromil sodium within 2 weeks prior to visit 1
14. Patients who were treated with oral betamimetics within 2 weeks prior to visit 1
15. Patients who were treated with oral corticosteroids within 4 weeks prior to visit 1
16. Patients who were treated with theophylline within 2 weeks prior to visit 1
17. Patients who were treated with leucotriene modifiers within 4 weeks prior to visit 1
18. Patients who were treated with omalizumab within 4 weeks prior to visit 1
19. Patients with known hypersensitivity to anticholinergic drugs or any other components of the inhalation solution used in the Respimat® inhaler
20. Patients with known hypersensitivity to salmeterol xinafoate or any other components of the salmeterol MDI
21. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are not surgically sterile; or are nursing or pregnant; or are of child-bearing potential and are not practicing acceptable means of birth control, do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable means of birth control include the transdermal patch, oral, implantable or injectable contraceptives, Intra Uterine Devices (IUDs), condoms, sexual abstinence and vasectomised partner. No exceptions will be made.
22. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to visit 1
23. Patients with previous participation (receipt of randomised treatment) in this study
24. Patients who are currently partici
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method