Chronic obstructive pulmonary disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Spiriva 18 microgram
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TIOTROPIUM BROMIDE
CAS Number: 139404481
Current Sponsor code: Ba 679 BR
Concentration unit:
Sponsors
Boehringer Ingelheim AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) The patient has signed an Informed Consent Form in accordance with GCP and local legislative requirements prior to participation in the trial, i.e., prior to pre-trial washout of any restricted medications. 2.) The patient has a clinical diagnosis of COPD. 3.) The patient has relatively stable, moderate to severe airway obstruction. 4.) The patient has a pre-bronchodilator FEV1 less than or equal to 65% of predicted normal determined at Visit 1 using the following predicted equations (R94-1408): a) Males FEV1 predicted [L] = 4.30 x Height [metres] – 0.029 x Age [years] – 2.49 b) Females FEV1 predicted [L] = 3.95 x Height [metres] – 0.025 x Age [years] – 2.60 and a TGV(FRC) ?120% predicted normal at visit 1 (or historical data not older than 6 month) c) Males TGV(FRC) pred. [L] = 2.34 x Height [metres] + 0.009 x Age [years] – 1.09 d) Females TGV(FRC) pred. [L] = 2.24 x Height [metres] + 0.001 x Age [years] – 1.00 5.) The patient is at least 40 years and less than or equal to 75 years old. 6.) The patient has a cigarette smoking history of at least 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year. 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.) The patient has a significant disease other than COPD. A significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the trial or may influence the results of the trial or the patient's ability to participate in the trial. 2.) The patient has a recent history of myocardial infarction within the year prior to Visit 1. 3.) The patient with a recent history of heart failure, pulmonary oedema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise described in Appendix 10.1 of the Clinical Trial Protocol within the last 3 years prior to Visit 1. 4.) The patient uses daytime supplemental oxygen. 5.) The patient has a diagnosis of known active tuberculosis. 6.) The patient has a history of cancer within the last 5 years prior to Visit 1. Patients with treated basal cell carcinoma are eligible. 7.) The patient has a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. 8.) The patient has undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons will be evaluated as per the first exclusion criterion (i.e., significant disease other than COPD). 9.) The patient has suffered from an upper respiratory tract infection or an exacerbation of COPD in the last 6 weeks prior to the screening visit (Visit 1) or during the run-in period. 10.) The patient has a known hypersensitivity to anticholinergic drug, ß-adrenergic or corticosteroids, lactose or any other component of the inhalation capsule delivery system. 11.) The patient has a known symptomatic prostatic hypertrophy or bladder neck obstruction. Patients with symptomatically controlled prostatic hypertrophy on medication may be included and should continue their medications. 12.) The patient has a known moderate or severe renal insufficiency. 13.) The patient has known narrow-angle glaucoma. 14.) The patient has known untreated hypokalemia. 15.) The patient has known untreated thyrotoxicosis. 16.) 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 Norplant). 17.) The patient has a history of or active alcohol or drug abuse. 18.) The patient has taken an investigational drug within 1 month or 10 half lives (whichever is greater) prior to Visit 1. 19.) The patient has a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity. 20.) The patient has been treated with monoamine oxidase inhibitors or tricyclic antidepressants within one month prior to Visit 1 or during the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective includes assessment of safety.;Main Objective: The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. ;Primary end point(s): The primary efficacy parameters are defined as thoracic gas volume (functional residual volume)(TGV(FRC)) and endurance time (ET) during a constant work rate exercise test to symptom limitation. Two co-primary efficacy endpoints are defined: - Post-dose TGV(FRC) after 8 weeks of investigational treatment. - Endurance time to the point of symptom limitation during a constant work rate exercise test at 75% Wcap after 8 weeks of investigational treatment. The baseline measurement for both co-primary endpoints is defined as pre-dose measurement (prior to first administration of randomised treatment) on Day 1. The two co-primary endpoints will be measured post dosing. Note that for each patient two values for each primary endpoint will be observed due to the crossover design, for one treatment at Day 57 (end of first period) and at Day 113 (end of second period) for the other treatment. | — |
Countries
Austria, France, Germany, Italy, Sweden
Outcome results
None listed