chronic obstructive pulmonary disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Spiriva
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tiotropium Bromide
CAS Number: 139404481
Current Sponsor code: BA 679 BR
Concentration unit: µg microgram(
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1: Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 = 70% of predicted normal and FEV1 = 70% of FVC postbronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC [R94-1408]. For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) – 2.49 Females: FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) – 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) – 0.029 x age (years) –2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres))- 0.025 x age (years) – 2.60 2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial. 3. Male or female patients 40 years of age or older. 4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation. 5. Patients must be current or ex-smokers with a smoking history of = 10 pack-years. (Patients who have never smoked cigarettes must be excluded.) Pack Years = (Number of cigarettes/day)/20 x years of smoking 6. Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs). 7. Patients must be able to inhale medication in a competent manner from the HandiHaler® (Appendix 10.1) and a metered dose inhaler (MDI) (Appendix 10.2). 8. Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol. 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: 1. Significant diseases other than COPD. 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 patients’ ability to participate in the study. 2. Patients with a diagnosis of asthma. 3. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis. 4. Patients with known active tuberculosis. 5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication. 6. Patients with known narrow-angle glaucoma. 7. Patients with a history of myocardial infarction within the year prior to Visit 1. 8. Patients with a history of hospital admission for heart failure within the year prior to Visit 1. 9. Patients with cardiac arrhythmia requiring medical or surgical treatment. 10. Patients with severe cardiovascular disorders. 11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other component of the medication delivery system. 12. Patients with known moderate or severe renal insufficiency (known creatinine clearance of = 50 mL/min). 13. Patients with untreated known hypokalaemia. 14. Patients with untreated known thyrotoxicosis. 15. Patients with brittle/unstable diabetes mellitus. 16. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1. 17. Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater) prior to Screening Visit (Visit 1). 18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day. 19. 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 three months prior to, and for the duration of the trial. 20. Previous participation (receipt of randomised treatment) in this study. 21. Patients who are currently participating in another study. 22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the latter may be extended up to four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler® and salmeterol (50 mcg) via MDI on COPD exacerbations.;Secondary Objective: ;Primary end point(s): The primary endpoint is the time to first COPD exacerbation. For the purpose of this study a COPD exacerbation will be defined as: A complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospital admission. | — |
Countries
Austria, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Portugal, Slovenia, Spain, United Kingdom
Outcome results
None listed