Patients with severe persistent asthma MedDRA version: 8.1 Level: LLT Classification code 10003555 Term: Asthma bronchial
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and local legalisation prior to participation in the trial (i.e. prior to any study procedures, including any pre-study washout of medications and medication restrictions for pulmonary function test at Visit 1). 2. Male or female patients 18 years of age or older, but not older than 75 years. 3. Patients must have an ACQ mean score at screening (Visit1) of >/= 1.5. 4. Patients must be symptomatic (as defined in inclusion criterion #3) and at least 6 weeks on a high, stable dose of inhaled corticosteroids* + a long-acting beta adrenergic (additional sustained release theophylline and/or leukotriene modifier and/or oral glucocorticosteroids (cf. exclusion criterion No.13) are allowed in stable doses) * budesonide DPI >/=800 µg per day beclomethasone CFC >/=1000 µg per day beclomethasone HFA >/=500 µg per day Fluticasone >/= 500 µg per day Flunisolide >/=2000 µg per day mometasone furoate >/=800 µg per day triamcinolone acetonide >/=2000 µg per day Ciclesonide >/= 640 µg per day 5. Patients must be never smokers or ex-smokers with a cigarette smoking history of 15% of PEF or FEV1; or a PEF variability > 15%), and a current diagnosis of severe, persistent asthma and must meet the following spirometric criteria: Post bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol) FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 clinically relevant abnormal baseline haematology or blood chemistry will be excluded. 3. Patients with a recent history (i.e., six months or less) of myocardial infarction. 4. Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year. 5. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 6. 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. 7. Patients with lung diseases other than asthma (e.g. COPD). 8. Patients with known active tuberculosis. 9. Patients with significant alcohol or drug abuse within the past two years. 10. 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. 11. Patients who are in a pulmonary rehabilitation program. 12. Patients who are being treated with Omalizumab (Xolair®) 13. Patients using oral corticosteroid medication at stable doses exceeding 5 mg/d prednisolone or prednisolone equivalent every day or 10 mg/d prednisolone or prednisolone equivalent every second day. 14. Patients who are being treated with beta-blocker medication. Topical cardio-selective beta-blocker eye medication for treatment of non-narrow angle glaucoma are allowed. 15. Patients with known hypersensitivity to anticholinergic drugs or any other components of the tiotropium inhalation solution. 16. 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 17. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Visit 1. 18. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1. 19. Patients with any respiratory infections in the four weeks prior to the Screening Visit (Visit 1) or during the 2-week baseline period. In the case of a respiratory infection during the baseline period the latter may be extended up to six weeks. 20. Patients who are currently participating in another study. 21. Patients with prostatic hyperplasia, bladder-neck obstruction, or known narrow-angle glaucoma. 22. Patients with moderate to severe renal impairment (creatinine clearance = 50 mL/min). 23. Patients who are being treated with TNF-alpha-blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to examine efficacy and safety of two doses [5 mcg (2 actuations of 2.5 mcg) and 10 mcg (2 actuations of 5 mcg)] of tiotropium inhalation solution delivered by the Respimat inhaler once daily as add-on therapy compared to placebo at the end of the 8-week periods of randomised treatment.;Secondary Objective: To assess the safety of tiotropium add-on therapy in severe asthmatics treated with inhaled steroids and long-acting beta-adrenergics;Primary end point(s): The primary efficacy endpoint is the peak FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period. | — |
Countries
Denmark, Germany, Netherlands
Outcome results
None listed