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)

Pulmonary Disease, Chronic Obstructive Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144326
• Other study ID #: 205.269
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: October 31, 2013
• Start date: July 2003
• Est. completion date: October 2005

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosCanada: Health CanadaGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium Bromide

• Placebo

Locations

Country	Name	City	State
Canada	1796 Summer Street	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Montreal Chest Institute of the Royal Victoria Hospital	Montreal	Quebec
Canada	Department of Respiratory Medicine	Saskatoon	Saskatchewan
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	Respiratory/ Research Lab	Toronto	Ontario
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
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	Hannover
Germany	Klinik III für Innere Medizin/ Pneumologie	Köln
Germany	Boehringer Ingelheim Investigational Site	Rüdersdorf
Spain	Hospital Universitario Príncipe de Asturias	Alcalá de Henares (Madrid)
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Centro de Asistencia Primaria de Campdevanol	Campdevànol (Girona)
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Canada,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.

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