Chronic obstructive pulmonary disease (COPD) MedDRA version: 12.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Code: Ba 679 BR
Pharmaceutical Form: Inhalation vapour
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions. 2. Male or female patients 40 years of age or older. 3. Patients must be current or ex-smokers with a smoking history of = 10 pack- years (patients who have never smoked cigarettes must be excluded). 4. All patients must have a diagnosis of COPD and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Significant diseases other than COPD. 2. Patients with a recent history (i.e., six months or less) of myocardial infarction. 3. Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the past year. 4. Hospitalisation for cardiac failure during the past year. 5. 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 history of asthma or who have a total blood eosinophil count greater than 600/mm3. 7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. 8. Known active tuberculosis. 9. Patients with a history (within the past two years) of and / or active significant alcohol or drug abuse. 10. Patients who have undergone thoracotomy with pulmonary resection. 11. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to screening or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study. 12. Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy. 13. Patients who have taken an investigational drug during the four week period prior to screening. 14. Use of antihistamines (H1 receptor antagonists), anti-leukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. 15. Use of cromolyn sodium or nedocromil sodium. 16. Use of systemic corticosteroid medication at unstable doses. 17. Known hypersensitivity to anticholinergic drugs, ß2-adrenergic drugs, lactose or any other component of the study medication delivery systems. 18. Pregnant or nursing women 19. Women of childbearing potential not using a highly effective method of birth control. 20. Treatment with oral beta-adrenergics within 4 weeks prior to screening or during the run-in period. 21. Treatment with indacaterol. 22. Treatment with tiotropium within 2 weeks prior to screening and within 3 weeks prior to randomisation. 23. Treatment with theophylline within specified time windows prior to screening. 24. Patients who are currently participating in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise the pharmacokinetics (systemic exposure to tiotropium) of once-daily tiotropium administered from the Respimat inhaler in doses of 1.25mcg, 2.5mcg and 5 mcg solution for inhalation and compare to tiotropium administered from the HandiHaler at a dose of 18 mcg inhalation powder following 4-week treatment periods.;Secondary Objective: To compare the safety (Holter ECG monitoring) and efficacy (FEV1, FVC) of tiotropium, 1.25mcg, 2.5mcg and 5mcg when administered as a solution for inhalation from the Respimat inhaler and as an inhalation powder (18mcg) from the HandiHaler.;Primary end point(s): The primary endpoints are Cmax,ss (maximum measured concentration of tiotropium in plasma at steady-state) AUC 0-6,ss (Area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours after inhalation at steady-state). | — |
Countries
Denmark, Finland, Germany, Netherlands
Outcome results
None listed