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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)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiotropium Bromide
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

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.

Full Information

First Posted
September 2, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00144326
Brief Title
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)
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).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium Bromide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Spain S.A.
Official's Role
Study Chair
Facility Information:
Facility Name
1796 Summer Street
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V6
Country
Canada
Facility Name
Respiratory/ Research Lab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Montreal Chest Institute of the Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P4
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Department of Respiratory Medicine
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
13597
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Krankenhaus Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fürth
ZIP/Postal Code
90762
Country
Germany
Facility Name
Inamed Research GmbH & Co. KG
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
City
Hamburg
ZIP/Postal Code
20535
Country
Germany
Facility Name
Allergomedic
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Klinik III für Innere Medizin/ Pneumologie
City
Köln
ZIP/Postal Code
50922
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Hospital Universitario Príncipe de Asturias
City
Alcalá de Henares (Madrid)
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Centro de Asistencia Primaria de Campdevanol
City
Campdevànol (Girona)
ZIP/Postal Code
17530
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10001
Country
Spain
Facility Name
Hospital Universitario Reína Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General de Elche
City
Elche (Alicante)
ZIP/Postal Code
02303
Country
Spain
Facility Name
Hospital Ntra. Sra. de Meritxell
City
Escaldes-Engordany
Country
Spain
Facility Name
Centro de Asistencia Primaria de la Roca
City
La Roca del Vallés (Barcelona)
ZIP/Postal Code
08430
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Vírgen de la Victoria
City
Málaga
ZIP/Postal Code
29080
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.269.pdf
Description
Related Info

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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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