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)

NCT00144326 | Completed Phase 3

• 1 other identifier: 205.269
• Study Type: interventional
• Target: 250
• Locations: 3 countries
• Sites: 27

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Tiotropium Bromide DRUG

Placebo DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (27)

1796 Summer Street

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V6, Canada

Location

Respiratory/ Research Lab

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal Chest Institute of the Royal Victoria Hospital

Montreal, Quebec, H2X 1P4, Canada

Location

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Department of Respiratory Medicine

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Boehringer Ingelheim Investigational Site

Berlin, 13597, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 14057, Germany

Location

Klinik III für Innere Medizin/ Pneumologie

Cologne, 50922, Germany

Location

Krankenhaus Donaustauf

Donaustauf, 93093, Germany

Location

Boehringer Ingelheim Investigational Site

Fürth, 90762, Germany

Location

Inamed Research GmbH & Co. KG

Gauting, 82131, Germany

Location

Pneumologisches Forschungsinstitut GmbH

Großhansdorf, 22927, Germany

Location

Pneumologisches Forschungsinstitut GmbH am Krankenhaus

Hamburg, 20535, Germany

Location

Allergomedic

Hanover, 30159, Germany

Location

Boehringer Ingelheim Investigational Site

Rüdersdorf, 15562, Germany

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares (Madrid), 28805, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Centro de Asistencia Primaria de Campdevanol

Campdevànol (Girona), 17530, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10001, Spain

Location

Hospital Universitario Reína Sofía

Córdoba, 14004, Spain

Location

Hospital General de Elche

Elche (Alicante), 02303, Spain

Location

Hospital Ntra. Sra. de Meritxell

Escaldes-Engordany, Spain

Location

Centro de Asistencia Primaria de la Roca

La Roca Del Vallés (Barcelona), 08430, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Vírgen de la Victoria

Málaga, 29080, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Spain S.A.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: July 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (10); ES (11); CA (6)