A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)

• Conditions: Chronic Obstructive Pulmonary Disease (COPD).

• Registration Number: EUCTR2006-001009-27-DK
• Lead Sponsor: Boehringer Ingelheim (UK) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified