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)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144326
First received: September 2, 2005
Last updated: October 31, 2013
Last verified: October 2013

September 2, 2005
October 31, 2013
July 2003
October 2005   (final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00144326 on ClinicalTrials.gov Archive Site
Pulmonary function tests, distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL measured by the CRQ, use of rescue salbutamol, and safety variables.
Pulmonary Function Tests, Distance covered in the 6MWD, Modified Borg Dyspnea scale, QoL mesured by the CRQ, use of rescue salbutamol, and safety variables
Not Provided
Not Provided
 
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)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Tiotropium Bromide
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Spain
 
NCT00144326
205.269
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Spain S.A.
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP