Chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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 vap
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG, Medical Affairs Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, includes medication washout and restrictions. 2. Male or female patients aged 40 years of age or over 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 =70% of predicted normal and post-bronchodilator FEV1 / FVC =70% 5. Patients must be able to inhale from the HandiHaler® and the Respimat® devices. 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 8500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8600
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 last year. 4. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year. 5. Known active tuberculosis. 6. Patients with a history of asthma, cystic fibrosis, clinically evident bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease 7. A history of thoracotomy with pulmonary resection. 8. Patients planning to undergo lung transplant or lung volume reduction surgery (LVRS). 9. Malignancy for which the patient has undergone resection, radiation, chemotherapy or biological treatments within the last five years. Patients with treated basal cell carcinoma are allowed. 10. A respiratory infection or exacerbation of COPD in the four weeks prior to randomization. 11. Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA) or any other components of the HandiHaler® or Respimat® inhalation solution delivery system. 12. Patients with known moderate to severe renal impairment (as judged by the investigator). 13. Patients with known narrow angle glaucoma. 14. Patients with significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included. 15. Use of systemic corticosteroid medication at unstable doses. 16. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. 17. Significant alcohol or drug abuse within the past 12 months. 18. Patients requiring the use of supplemental oxygen therapy for >12 hours per day 19. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study. 20. Patients who have taken an investigational drug within 30 days prior to Screening Visit. 21. Previous participation (receipt of randomised treatment) in this study. 22. Patients who are currently participating in an interventional study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of COPD exacerbations - Time to first hospitalisation due to COPD exacerbation - Number of hospitalisations due to COPD exacerbations - Time to first major adverse cardiovascular event;Timepoint(s) of evaluation of this end point: Number of COPD exacerbations: see E.5.1.1 Time to first hospitalisation due to COPD exacerbation, Number of hospitalisations due to COPD exacerbations, Time to first major adverse cardiovascular event: will be evaluated ongoing by assessing Adverse Events at all visits during treatment period, End-Of Treatment visit and Follow-up contact. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of 2.5mcg and 5mcg Tiotropium Inhalation Solution delivered by the Respimat Inhaler with Tiotropium inhalation capsules 18mcg delivered by the HandiHaler.;Secondary Objective: No secondary objectives are defined;Primary end point(s): The first primary endpoint is time to all-cause mortality. The second primary endpoint is time to first COPD exacerbation. A COPD exacerbation is defined as a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment. ;Timepoint(s) of evaluation of this end point: Patients will be given reminder cards to record changes in concomitant medications used to treat a COPD exacerbation. These cards will serve as a reminder for the patients, to be reviewed by the investigator at each visit to ensure that all COPD exacerbations have been recorded and that the exacerbations meet the definition listed above. The reminder cards will be collected as part of the permanent patient record. Exacerbations will be recorded in the eCRF. The same questions and review of patient symptoms regarding exacerbations will be asked during the interim contacts between treatment visits and will be recorded in the eCRF. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed