Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis and emphysema
Conditions
Interventions
Trade Name: Spiriva 18 microgram
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tiotropium bromide
Current Sponsor code: Ba 679 BR
Concentration unit: µg microgram(s)
Concen
Sponsors
Boehringer Ingelheim Pharma GmbH
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. 2. Male or female patients 40 years of age or older. 3. Current or ex-smokers with a smoking history of >/= to 10 pack years. Patients who have never smoked cigarettes must be excluded. 4. Use of Combivent® Inhalation Aerosol MDI for maintenance COPD treatment at least one month prior to screening. 5. All patients must have a diagnosis of chronic obstructive pulmonary disease (re:ATS/ERS statement on COPD), relatively stable airway obstruction, and must meet the following spirometric criteria: • At Visit 1 – 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 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. Clinical history of asthma. 3. History of thoracotomy with pulmonary resection. 4. Regularly use daytime supplemental 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 supplemental oxygen therapy during testing. 5. Use of systemic corticosteroids in an unstable daily dose (less than 6 weeks on a stable dose) or a daily dose of >10 mg of prednisone or its equivalent. 6. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial Visit 1. 7. Recent history (i.e., 6 months or less) of myocardial infarction. 8. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year. 9. Currently undergoing radiation therapy or chemotherapy for a malignancy. 10. Pregnant or nursing 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. 11. Participation in another trial with investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study. 12. Known hypersensitivity to anticholinergic drugs, soya lecithin or related food products such as soybean and peanut, lactose or any other components of the study medications or derivatives. 13. Current or recent (within 4 weeks of Visit 1) participation in a pulmonary rehabilitation program. 14. Significant alcohol or drug abuse in the previous year. 15. Use of commercially available Spiriva in the preceding 3 months. 16. Current treatment with beta-blocker medications. 17. Current treatment with oral beta-adrenergics. 18. Use of cromolyn sodium or nedocromil sodium, antileukotrienes or leukotriene receptor antagonists within 3 months of Visit 1. 19.Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants. 20. Use of regularly scheduled ipratropium (Atrovent® MDI, nebulizer, or nasal solution) or other short-acting anticholinergic (i.e. oxitropium), nebulized combination of ipratropium and albuterol or other combination of anticholinergic and beta agonist in any formulation (ie:Berdual®)in the previous month. 21. Symptomatic prostatic hypertrophy or bladder neck obstruction. Patients with symptomatically controlled prostatic hypertrophy on medications may be included and should continue their medications. 23. Known narrow-angle glaucoma. 24. Current participation in another interventional study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the efficacy and safety of 12 weeks treatment with tiotropium via HandiHaler® 18 mcg daily or Combivent® MDI 2 actuations q.i.d. in COPD patients currently prescribed Combivent® MDI. ;Secondary Objective: The secondary objectives of the trial are to further evaluate the efficacy of the treatment with tiotropium via HandiHaler® 18 mcg daily or Combivent® MDI 2 actuations in reducing use of rescue medication (albuterol) and improving peak expiratory flow rates (measured daily in the morning and evening) during the treatment period. Patient and physician global evaluation ratings will also be evaluated and compared for the two treatment groups. Other spirometric parameters including: Peak FEV1 at 12 weeks, peak, FEV1 AUC0-6 hours after first dose and 6 weeks, trough FEV1 at six weeks and individual FEV1 measurements at each timepoint and corresponding FVC measurements will also be evaluated as secondary endpoints. ;Primary end point(s): The co-primary efficacy endpoints will be the trough FEV1 and FEV1 AUC0-6 hours after 12 weeks of treatment. | — |
Countries
Lithuania, Slovakia, United Kingdom
Outcome results
None listed