A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria: All patients must sign an Informed Consent Form consistent with ICH-GPC guidelines prior to participation in the trial Diagnosis of COPD and meets the following spirometric criteria: The patients must present with relatively stable* airway obstruction An FEV1 <= 65% of the predicted normal value and an FEV1 <= 70% of the FVC, at visit 1 (screening). This must be confirmed at visit 2 (baseline). Male or female patients of 40 years of age or older. The patients must be smokers or ex-smokers with a history of having smoked at least 10 pack-years. The patients must be able to carry out all the tests related to the study, including the slow and forced spirometry and the 6 minute walk test, exactly as required in the protocol. The patients must be able to inhale the medication by means of the HandiHaler. Exclusion Criteria: Those patients with significant diseases other than COPD will be excluded. Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during the study. Patients with any respiratory tract infection in the past six weeks prior to the screening visit (Visit 1) or during the run-in period, prior to Visit 2 (baseline). Patients with a past history of asthma, allergic rhinitis or atopy, or who present a total eosinophil count >= 600 mm3. No new eosinophil count will be undertaken in these patients.
Sites / Locations
- 1796 Summer Street
- Kingston General Hospital
- Respiratory/ Research Lab
- Montreal Chest Institute of the Royal Victoria Hospital
- Hopital Laval
- Department of Respiratory Medicine
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Krankenhaus Donaustauf
- Boehringer Ingelheim Investigational Site
- Inamed Research GmbH & Co. KG
- Pneumologisches Forschungsinstitut GmbH
- Pneumologisches Forschungsinstitut GmbH am Krankenhaus
- Allergomedic
- Klinik III für Innere Medizin/ Pneumologie
- Boehringer Ingelheim Investigational Site
- Hospital Universitario Príncipe de Asturias
- Hospital Clinic i Provincial de Barcelona
- Centro de Asistencia Primaria de Campdevanol
- Hospital San Pedro de Alcántara
- Hospital Universitario Reína Sofía
- Hospital General de Elche
- Hospital Ntra. Sra. de Meritxell
- Centro de Asistencia Primaria de la Roca
- Hospital de la Princesa
- Hospital Universitario La Paz
- Hospital Vírgen de la Victoria