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)
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Purpose
The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18 mcg once daily by oral inhalation compared to placebo increases the magnitude of daily physical activity observed in COPD patients, measured using an accelerometer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium Bromide Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect, of Tiotropium Inhalation Capsules on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD). |
- Primary endpoint: The primary efficacy variable will be the difference in physical activity measured in vector magnitude units (VMUs) by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo.
- Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.
| Enrollment: | 250 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
This is a 3 month, multicentre, randomised, double-blind, placebo controlled, parallel group study to compare with placebo the long-term effect of tiotropium inhalation capsules on daily physical activity in patients with COPD.
The drugs will be administered in the form of inhalation capsules of tiotropium or placebo, taken once daily in the morning.
The record of daily physical activity using the accelerometer will be carried out at all study visits other than Visit 1. The accelerometer will be used for the five day period, from Thursday to Monday, closest to the corresponding visit.
The pulmonary function tests will be carried out at Visit 1 (screening visit), Visit 2 (baseline visit) and study visits (Visits 3 to 5) with the restrictions detailed at the trial protocol.
Study Hypothesis:
The null hypothesis is that there is no difference between tiotropium (Spiriva) and placebo regarding the magnitude of exercise measured with an accelerometer. The alternative hypothesis is that there is a difference between tiotropium (Spiriva) and placebo regarding the magnitude of exercise measured with an accelerometer.
Comparison(s):
The difference in physical activity measured in vector magnitude units (VMUs) by the triaxial Stayhealthy RT3 accelerometer at the end of the three month treatment period compared to placebo.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00144326
| Canada, Nova Scotia | |
| 1796 Summer Street | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V6 | |
| Respiratory/ Research Lab | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| Montreal Chest Institute of the Royal Victoria Hospital | |
| Montreal, Quebec, Canada, H2X 1P4 | |
| Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Canada, Saskatchewan | |
| Department of Respiratory Medicine | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Germany | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany, 14057 | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany, 13597 | |
| Krankenhaus Donaustauf | |
| Donaustauf, Germany, 93093 | |
| Boehringer Ingelheim Investigational Site | |
| Fürth, Germany, 90762 | |
| Inamed Research GmbH & Co. KG | |
| Gauting, Germany, 82131 | |
| Pneumologisches Forschungsinstitut GmbH | |
| Großhansdorf, Germany, 22927 | |
| Pneumologisches Forschungsinstitut GmbH am Krankenhaus | |
| Hamburg, Germany, 20535 | |
| Allergomedic | |
| Hannover, Germany, 30159 | |
| Klinik III für Innere Medizin/ Pneumologie | |
| Köln, Germany, 50922 | |
| Boehringer Ingelheim Investigational Site | |
| Rüdersdorf, Germany, 15562 | |
| Spain | |
| Hospital Universitario Príncipe de Asturias | |
| Alcalá de Henares (Madrid), Spain, 28805 | |
| Hospital Clinic i Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Centro de Asistencia Primaria de Campdevanol | |
| Campdevànol (Girona), Spain, 17530 | |
| Hospital San Pedro de Alcántara | |
| Cáceres, Spain, 10001 | |
| Hospital Universitario Reína Sofía | |
| Córdoba, Spain, 14004 | |
| Hospital General de Elche | |
| Elche (Alicante), Spain, 02303 | |
| Hospital Ntra. Sra. de Meritxell | |
| Escaldes-Engordany, Spain | |
| Centro de Asistencia Primaria de la Roca | |
| La Roca del Vallés (Barcelona), Spain, 08430 | |
| Hospital de la Princesa | |
| Madrid, Spain, 28006 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Vírgen de la Victoria | |
| Málaga, Spain, 29080 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Spain S.A. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00144326 History of Changes |
| Other Study ID Numbers: | 205.269 |
| Study First Received: | September 2, 2005 |
| Last Updated: | October 31, 2013 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Tiotropium Anti-Asthmatic Agents Autonomic Agents Bronchodilator Agents Cholinergic Agents |
Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Parasympatholytics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015