Clinical trial NCT00144326: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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 outcomes:
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.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: 1796 Summer Street
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Respiratory/ Research Lab
state: Ontario
city: Montreal
country: Canada
facility: Montreal Chest Institute of the Royal Victoria Hospital
state: Quebec
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Saskatoon
country: Canada
facility: Department of Respiratory Medicine
state: Saskatchewan
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Donaustauf
country: Germany
facility: Krankenhaus Donaustauf
city: Fürth
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gauting
country: Germany
facility: Inamed Research GmbH & Co. KG
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut GmbH
city: Hamburg
country: Germany
facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus
city: Hannover
country: Germany
facility: Allergomedic
city: Köln
country: Germany
facility: Klinik III für Innere Medizin/ Pneumologie
city: Rüdersdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Alcalá de Henares (Madrid)
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Campdevànol (Girona)
country: Spain
facility: Centro de Asistencia Primaria de Campdevanol
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Universitario Reína Sofía
city: Elche (Alicante)
country: Spain
facility: Hospital General de Elche
city: Escaldes-Engordany
country: Spain
facility: Hospital Ntra. Sra. de Meritxell
city: La Roca del Vallés (Barcelona)
country: Spain
facility: Centro de Asistencia Primaria de la Roca
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Vírgen de la Victoria
Study officials:
affiliation: B.I. Spain S.A.
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: