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)
NCT ID: NCT00144326
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2003-07-31
2005-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tiotropium Bromide
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
B.I. Spain S.A.
Locations
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1796 Summer Street
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Respiratory/ Research Lab
Toronto, Ontario, Canada
Montreal Chest Institute of the Royal Victoria Hospital
Montreal, Quebec, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
Department of Respiratory Medicine
Saskatoon, Saskatchewan, Canada
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Klinik III für Innere Medizin/ Pneumologie
Cologne, , Germany
Krankenhaus Donaustauf
Donaustauf, , Germany
Boehringer Ingelheim Investigational Site
Fürth, , Germany
Inamed Research GmbH & Co. KG
Gauting, , Germany
Pneumologisches Forschungsinstitut GmbH
Großhansdorf, , Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg, , Germany
Allergomedic
Hanover, , Germany
Boehringer Ingelheim Investigational Site
Rüdersdorf, , Germany
Hospital Universitario Príncipe de Asturias
Alcalá de Henares (Madrid), , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Centro de Asistencia Primaria de Campdevanol
Campdevànol (Girona), , Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital Universitario Reína Sofía
Córdoba, , Spain
Hospital General de Elche
Elche (Alicante), , Spain
Hospital Ntra. Sra. de Meritxell
Escaldes-Engordany, , Spain
Centro de Asistencia Primaria de la Roca
La Roca Del Vallés (Barcelona), , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Vírgen de la Victoria
Málaga, , Spain
Countries
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Other Identifiers
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205.269
Identifier Type: -
Identifier Source: org_study_id