A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma - TinA in severe asthma 2
- 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 treatments 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
- EUCTR2008-001414-25-GB
- Lead Sponsor
- Boehringer Ingelheim Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1. Signed and dated Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to participation in the trial
2. Male or female patients aged at least 18 years but not more than 75 years.
3. At least a 5-year history of asthma (GINA 2007)
4. Diagnosis of asthma 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 (Xolair®) and/or oral glucocortico-steroids are allowed in stable doses.
7. ACQ mean score of >= 1.5 at screening and randomisation visits.
8. History of one or more asthma exacerbation in the past year that required an addition or increased dose of systemic corticosteroids.
9. Post bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol/albuterol) FEV1 = 80% of predicted normal and FEV1 = 70% of FVC
10. Variation of FEV1 at visit 1 and visit 2 must be within +/- 30%
11. 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.
12. Able to use the Respimat inhaler correctly
13. Able to perform all trial related procedures
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. Any significant disease other than asthma which 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. Clinically relevant abnormal screening haematology or blood chemistry if the abnormality defines a significant disease
3. Recent history (i.e. six months or less) of myocardial infarction.
4. Hospitalisation for cardiac failure during the past year.
5. Unstable or life threatening cardiac arrhythmia or cardiac arrhythmia within the past year requiring intervention or a change in drug therapy within the past year.
6. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
7. Lung diseases other than asthma (e.g. COPD).
8. Known active tuberculosis.
9. Alcohol or drug abuse within the past two years.
10. Past thoracotomy with pulmonary resection.
11. Currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit.
12. Oral corticosteroid medication at stable doses >=5 mg prednisolone
13. 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
17. Patients who have been treated with tiotropium within four weeks
18. Patients who have been treated with beta-blocker medication within four weeks
19. Patients who have been treated with oral beta-adrenergics within four weeks
20. Patients who have been treated with other non-approved and according to international guidelines not recommended ´experimental´ drugs for routine asthma therapy (e.g. TNF-alpha blockers, methotrexate, cyclosporin) within four weeks
21. Any asthma exacerbation in the four weeks prior
22. Any respiratory tract infection in the four weeks prior
23. Patients who have previously been randomised in this trial or in the respective twin trial or are currently participating in another trial.
24. Known narrow-angle glaucoma
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