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)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144326
First received: September 2, 2005
Last updated: October 31, 2013
Last verified: October 2013
  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).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144326

Locations
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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014