Patients with COPD (chronic obstructive pulmonary disease) and a concomitant diagnosis of asthma (asthma bronchiale). MedDRA version: 7.0 Level: LLT Classification code 10010952
Conditions
Interventions
Trade Name: Spiriva(R) 18 Mikrogramm Kapsel mit Inhalationspulver
Product Name: Spiriva(R) 18 Mikrogramm Kapsel mit Inhalationspulver
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Propos
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients of either sex, aged = 40 years, with a diagnosis of COPD and a history of asthma (post bronchodilator FEV1 12% and at least 200ml from baseline 30 min. after 400µg 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with significant diseases other than COPD and asthma will be excluded. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient’s ability to participate in the study. 2. Patients with a history of a recent (i.e. six months or less) myocardial infarction. 3. Patients with unstable or life-threatening cardiac arrhythmias, including any patient with a newly diagnosed, clinically relevant arrhythmia on the ECG performed on Visit 1. Patients with arrhythmias requiring an intervention (i.e. hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year should also be excluded from the study. Patients stabilized with a pacemaker may participate in the study. 4. Patients who have been hospitalised for heart failure during last 3 months. 5. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. 6. 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. 7. Patients with any respiratory infection or exacerbation in the six weeks prior to Visit 1 or the Screening Period. These patients may be randomised six weeks following recovery from the infection or exacerbation. 8. Patients who regularly use daytime oxygen therapy for more than one hour per day and who, in the investigator’s opinion, will be unable to abstain from the use of oxygen therapy during testing. 9. Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program within four weeks of Visit 1. 10. Patients with known active tuberculosis. 11. Patients with a history of cancer within the past five years. Patients with treated basal cell carcinoma are allowed. 12. Pregnant or breastfeeding women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g. Norplant®) for at least 3 months prior to and for the duration of the trial. 13. Patients with known hypersensitivity to anti-cholinergic drugs, lactose or any other components of the inhalation capsule delivery system. 14. Patients with a history of significant alcohol or drug abuse in the previous year. (see exclusion criterion no. 1). 15. Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater), prior to Visit 1. 17. Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day. 18. Patients who documented in their diary cards the use of rescue medication (salbutamol) more than 8 puffs/day on 3 consecutive days during the run-in period should not be randomised. 19. Patients who are currently participating in another interventional study. 20. Patients with previous participation in this study. Precautionary statements: Tiotropium: ? As with other anti-cholinergic drugs, tiotropium should be used with caution in patients with prostatic hyperplasia, bladder-neck obstruction, or known narrow-angle glaucom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of tiotropium in patients with COPD and concomitant diagnosis of asthma.;Secondary Objective: To demonstrate the safety of tiotropium in patients with COPD and concomitant diagnosis of asthma.;Primary end point(s): The primary efficacy parameter is defined as forced expiratory volume in 1 second (FEV1). The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 6 hours post dose (AUC0 6hFEV1) after 12 weeks of randomised treatment on Day 85. | — |
Countries
Denmark, Germany, Italy
Outcome results
None listed