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 mcg once daily with that of salmeterol from the hydrofluoroalkane metered dose inhaler 2 puffs of 25 mcg twice daily in moderate persistent asthma patients homozygous for B16-Arg/Arg. - Tiotropium Salmeterol Study in asthma
- Conditions
- Patients with moderate persistent bronchial asthma and homozygous for arginine at the 16th position of the beta-2-adrenergic receptorMedDRA version: 6.1Level: PTClassification code 10003553
- Registration Number
- EUCTR2005-005616-25-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2500
1.Patients must be homozygous for arginine at the 16th amino acid position of the beta2 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 participation in the trial 3.Male or female outpatients with at least 18 years of age, but not older than 60 years 4.Patients must have a documented history of asthma 5.Patients must be current non-smokers or ex-smokers with a cigarette smoking history of 10 pack-years and smoking cessation at least one year prior to study enrolment 6.All patients must be on a maintenance treatment with inhaled corticosteroids alone or in a fixed combination with a LABA or a SABA 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 prior to visit 1 7.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 mcg salmeterol or at least 18 mcg formoterol within the last 3 months and a stable dose within the last 3 weeks prior to visit 1 are eligible if they meet the following spirometric criterion Pre-bronchodilator FEV1 90 of predicted normal at visit 1 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 Predicted normal values will be calculated according to ECSC 8.Reversibility of airways obstruction must be demonstrated by a reversibility test with ipratropium and salbutamol at visit 1. Patients inhale 4 puffs 80 mcg ipratropium from the MDI, PFT by spirometry is performed pre-dose first PFT and 45 minutes after ipratropium administration second PFT , then patients inhale 4 puffs 400 mcg from the salbutamol MDI and PFT is performed again 30 minutes after salbutamol administration third PFT . Patients must demonstrate an increase in FEV1 of at least 12 and 200 mL from the pre-dose PFT to the second PFT or from the pre-dose PFT to the third PFT. 9.Patients must be able to perform technically acceptable pulmonary function tests and Peak flow measurements with the electronic peak flow meter and must be able to perform all necessary recordings in the electronic diary as part of the electronic peak flow meter Asthma Monitor . 10.Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler MDI .
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. 2.Patients with 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 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 mechanical and/or chemical . 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 participating in another study 25.Patients with significant alcohol or drug abuse within the past two years 26.Patients with any respiratory tract infection or exacerbation in the four weeks prior to visit 1 or during the run-in period. 27.Patients requiring more than 12 puffs of rescue medication salbutamol MDI per 24 hours on 3 consecutive days during the run-in period should not be randomised
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