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)

October 31, 2013 updated by: Boehringer Ingelheim

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • 1796 Summer Street
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V6
        • Kingston General Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • Respiratory/ Research Lab
    • Quebec
      • Montreal, Quebec, Canada, H2X 1P4
        • Montreal Chest Institute of the Royal Victoria Hospital
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Hôpital Laval
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Department of respiratory medicine
  • Germany
      • Berlin, Germany, 13597
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 14057
        • Boehringer Ingelheim Investigational Site
      • Donaustauf, Germany, 93093
        • Krankenhaus Donaustauf
      • Fürth, Germany, 90762
        • Boehringer Ingelheim Investigational Site
      • Gauting, Germany, 82131
        • Inamed Research GmbH & Co. KG
      • Großhansdorf, Germany, 22927
        • Pneumologisches Forschungsinstitut GmbH
      • Hamburg, Germany, 20535
        • Pneumologisches Forschungsinstitut GmbH am Krankenhaus
      • Hannover, Germany, 30159
        • Allergomedic
      • Köln, Germany, 50922
        • Klinik III für Innere Medizin/ Pneumologie
      • Rüdersdorf, Germany, 15562
        • Boehringer Ingelheim Investigational Site
  • Spain
      • Alcalá de Henares (Madrid), Spain, 28805
        • Hospital Universitario Príncipe de Asturias
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Campdevànol (Girona), Spain, 17530
        • Centro de Asistencia Primaria de Campdevanol
      • Cáceres, Spain, 10001
        • Hospital San Pedro de Alcántara
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Elche (Alicante), Spain, 02303
        • Hospital General de Elche
      • Escaldes-Engordany, Spain
        • Hospital Ntra. Sra. de Meritxell
      • La Roca del Vallés (Barcelona), Spain, 08430
        • Centro de Asistencia Primaria de la Roca
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Málaga, Spain, 29080
        • Hospital Virgen de la Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Spain S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.269

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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