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.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Placebo  Drug: Tiotropium Bromide	Phase III

Further Study Details: 

Primary Outcomes: 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: Pulmonary Function Tests, Distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL mesured by the CRQ, use of rescue salbutamol, and safety variables
Expected Total Enrollment:  258

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 regading 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.

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

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, with 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00144326

Elena Gobartt, Dr.      +34 (93) 404-5706  Ext. 5706    Gobartt@bcn.boehringer-ingelheim.com

Canada
      Montreal Chest Institute - McGill University Health Centre, Montreal,  H2X 2P4,  Canada; Recruiting
      Kingston General Hospital, Kingston,  K7L 2V6,  Canada; Recruiting
Canada, Nova Scotia
      1796 Summer Street, Halifax,  Nova Scotia,  B3H 3A7,  Canada; Recruiting
Canada, Ontario
      Respiratory Research Lab, Toronto,  Ontario,  M5T 2S8,  Canada; Recruiting
Canada, Quebec
      Hopital Laval, Ste Foy,  Quebec,  G1V 4G5,  Canada; Recruiting
Canada, Saskatchewan
      c/o Hemodynamics Offices, Saskatoon,  Saskatchewan,  S7N 0W8,  Canada; Recruiting
Germany
      MEDARS GmbH, Berlin,  14057,  Germany; Recruiting
      Pneumologisches Forschungsinstitut GmbH am Krankenhaus, Hamburg,  20535,  Germany; Recruiting
      Klinikum der Universität Regensburg, Regensburg,  93053,  Germany; Recruiting
      Arzt für Innere Medizin, Berlin,  13597,  Germany; Recruiting
Germany, -
      IFG - Institut für Gesundheitsförderung GmbH, Rüdersdorf,  -,  15562,  Germany; Recruiting
      Facharzt für Lungen- und, Fürth,  -,  90762,  Germany; Recruiting
      DFS-Verwaltung, Köln,  -,  50935,  Germany; Recruiting
      Pneumologisches Forschungsinstitut GmbH, Grosshansdorf,  -,  22927,  Germany; Recruiting
      Inamed Research GmbH & Co. KG, Gauting,  -,  82131,  Germany; Recruiting
      Allergomedic, Hannover,  -,  30159,  Germany; Recruiting
Spain
      Hospital Clinic i Provincial de Barcelona, Barcelona,  08036,  Spain; Recruiting
      Hospital Universitario La Paz, Madrid,  28046,  Spain; Recruiting
      Hospital de la Princesa, Madrid,  28006,  Spain; Recruiting
      Hospital Universitario Príncipe de Asturias, Alcalá de Henares,  28805,  Spain; Recruiting
      Hospital General de Elche, Elche - Alicante,  02303,  Spain; Recruiting
      Hospital Vírgen de la Victoria, Málaga,  29080,  Spain; Recruiting
      Hospital Universitario Reína Sofía, CÓRDOBA,  14004,  Spain; Recruiting
      Hospital San Pedro de Alcántara, Cáceres,  10001,  Spain; Recruiting
      Centro de Asistencia Primaria de Campdevanol, Campdevànol (Girona),  17530,  Spain; Recruiting
      Centro de Asistencia Primaria de la Roca, La Roca del Vallés (Barcelona),  08430,  Spain; Recruiting
Spain, ANDORRA
      Hospital Ntra. Sra. de Meritxell, Escaldes-Engordany,  ANDORRA,  Spain; Recruiting

Study chairs or principal investigators

Elena Gobartt, Dr.,  Study Chair,  B.I. Spain S.A.   

Study ID Numbers:  205.269
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144326
Health Authority: Spain: Ministry of Health and Consumption; Canada: Health Canada; Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-06