Chronic Obstructive Pulmonary Disease (COPD).
Conditions
Interventions
Product Code: Tiotropium/Respimat inhaler
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: tiotropium bromide
CAS Number: 411207-31-3
Current Sponsor code: BA 679 BR
Concentration
Sponsors
Boehringer Ingelheim (UK) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged 40 years or more with a diagnosis of relatively stable, moderate to severe COPD and with a smoking history of at least 10 pack years will be eligible for inclusion in the trial. Patients must have a pre-bronchodilator FEV1 = 60% of predicted normal and FEV1 = 70% of FVC both at screening and on entry to the randomised phase of the trial. 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: Principal exclusion criteria are summarised as follows: 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. Recent history (i.e six months or less) of myocardial infarction. Unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year. Hospitalisation for cardiac failure during the past year. Malignancy requiring resection, radiation or chemotherapy within the last five years. Known narrow angle glaucoma. Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count = 600 / mm3. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. Known active tuberculosis. Patients with a history of and /or active significant alcohol or drug abuse. Patients who have undergone thoracotomy with pulmonary resection Patients who regularly use daytime oxygen therapy for more than 1 hour per day. 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 10mg prednisolone per day or 20mg every other day. Known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the Respimat inhalation solution delivery system. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this study is to evaluate the long-term (one-year) efficacy and safety of tiotropium inhalation solution 5µg (2 puffs of 2.5µg) delivered by the Respimat® inhaler compared to placebo in patients with Chronic Obstructive Pulmonary Disease. The primary objective will be comparison of bronchodilator efficacy (trough FEV1 response) after one-year of treatment and impact of treatment on time to first COPD exacerbation. ;Secondary Objective: Secondary objectives of the trial include evaluation of bronchodilator efficacy (trough FEV1 and trough FVC) at interim time points and other endpoints related to impact on COPD exacerbations. Additional secondary objectives of the study relate to assessment of the safety of long-term (one-year) treatment with tiotropium inhalation solution 5µg (2 puffs of 2.5µg) delivered by the Respimat® inhaler compared to placebo. Safety assessments will include monitoring of adverse events, pre- and post-study physical examination and 12-lead ECGs.;Primary end point(s): There will be two co-primary endpoints for this study: Trough FEV1 and time to first exacerbation. Bronchodilator efficacy will be assessed by trough FEV1 response. Trough FEV1 is defined as the FEV1 measured at the -10 minute time point at the end of the dosing interval (24 hours post drug administration). Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 will be the pre-treatment FEV1 measured at Visit 2 in the morning 10 minutes prior to the first dose of study medication. The effect of tiotropium on COPD exacerbations will be primarily determined by time to first moderate to severe exacerbation (according to the definitions provided in the study protocol) | — |
Countries
Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Portugal, Spain, Sweden
Outcome results
None listed