A Phase III randomised, double-blind, placebo-controlled, parallelgroup trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat inhaler (5 mcg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma - ND
- Conditions
- Patients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatment are allowed including systemic corticosteroids at stable doses (5mg/day) and others (like montelukast, omalizumab, etc.).MedDRA version: 9.1Level: LLTClassification code 10049106Term: Asthma chronic
- Registration Number
- EUCTR2008-001413-14-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
1. All patients must sign and date an Informed Consent Form consistent prior to any trial procedures. 2. Male or female patients aged at least 18 years but not more than 75 years. 3. All patients must have at least a 5-year history of asthma (GINA 2007) at the time of enrolment into the trial (confirmed in the past and documented by an increased hyperresponsiveness to histamine or methacholine; or a positive trial of glucocorticosteroids or a bronchodilator reversibility to a beta-2-adrenergic drug >= 15% of PEF or FEV1; or a PEF variability >= 15%). 4. The diagnosis of asthma must have been made before the patient?s age of 40. 5. All patients must have a diagnosis of severe persistent asthma and must be symptomatic despite treatment with high, stable doses of inhaled corticosteroids and a long-acting beta adrenergic agent. 6. All patients must have been on treatment with a high, stable dose of inhaled corticosteroids and a long-acting beta2 adrenergic agent for at least 4 weeks before the screening visit. Additional sustained release theophylline and/or leukotriene modifier and/or omalizumab and/or oral glucocorticosteroids are allowed in stable doses. 7. All patients must be symptomatic at screening (Visit1) as defined by an ACQ mean score of > 1.5. 8. All patients must have a history of one or more asthma exacerbation in the past year. Previous asthma exacerbation in this context is based on patientŽs recall and is defined by the sponsor as an unplanned need for medical care at any primary care physician, pulmonologist, emergency room or hospital due to an aggravation of asthma symptoms that required an addition or increased dose of systemic corticosteroids. Every effort should be made by the site to have an appropriate source documentation of these previous asthma exacerbations. 9. The patient must meet the following spirometric criteria at the screening (Visit 1): Post bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 mcg salbutamol/albuterol) FEV1 <= 80% of predicted normal and FEV1 <= 70% of FVC 10. Patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years. 11. Patients must be able to use the Respimat inhaler correctly. 12. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the electronic diary/peak flow meter.
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) yes
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 trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient?s ability to participate in the trial. 2. Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1. 3. Patients with a recent history (i.e. six months or less) of myocardial infarction. 4. Patients who have been hospitalised for cardiac failure during 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 currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1). 12. Patients using oral corticosteroid medication at stable doses exceeding 5 mg prednisolone or prednisolone equivalent every day or 10 mg prednisolone or prednisolone equivalent every second day. 13. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution. 14. Pregnant or nursing women. 15. Women of childbearing potential not using a highly effective method of birth control. 16. Patients who have taken an investigational drug within four weeks or six half-lives (whichever is greater) prior to Visit 1. 17. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva) within four weeks prior to the Screening Visit or during the screening period. 18. Patients who have been treated with beta-blocker medication within four weeks prior to Screening Visit or during the screening period. Topical cardio-selective beta-blocker eye medications for treatment of non-narrow angle glaucoma are allowed. 19. Patients who have been treated with oral beta-adrenergics within four weeks prior to Screening Visit or during the screening period. 20. Patients who have been treated with other non-approved and according to international guidelines not recommended ŽexperimentalŽ drugs for routine asthma therapy within four weeks prior to Screening Visit or during the screening period. 21. Patients with any asthma exacerbation in the four weeks prior to the Screening Visit or during the 2-week screening period. In the case of an asthma exacerbation during the screening period patients may be randomised four weeks following recovery from the exacerbation. 22. Patients with any respiratory tract infection in the four weeks prior to the Screening Visit or during the 2-week screening period. 23. Patients who have previously been randomised in this trial or in the respe
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