Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders

October 31, 2013 updated by: Boehringer Ingelheim

Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.

The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.

Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).

PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.

Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.

Study Hypothesis:

The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

Comparison(s):

Tiotropium 18 mcg once daily vs Placebo

Study Type

Interventional

Enrollment

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Clinique Saint Sauveur
      • Annecy, France, 74000
        • Boehringer Ingelheim Investigational Site
      • Aubagne, France, 13675
        • Clinique La Casamance
      • Avrille, France, 49240
        • Boehringer Ingelheim Investigational Site
      • Bois Guillaume cedex, France, 76233
        • Hopital
      • Caluire, France, 69300
        • GPL
      • Cholet, France, 49235
        • Ch Cholet
      • Cholet, France, 49300
        • Boehringer Ingelheim Investigational Site
      • Châlons en Champagne, France, 51000
        • Boehringer Ingelheim Investigational Site
      • Clermont-Ferrand cedex 1, France, 63003
        • Hôpital Gabriel Montpied
      • Cornebarrieu, France, 31700
        • Clinique des Cèdres
      • Epernay, France, 51200
        • Clinique Saint Vincent
      • Epernay, France, 51201
        • Centre Hospitalier Auban Moet
      • Le Blanc Mesnil cedex, France, 93156
        • Boehringer Ingelheim Investigational Site
      • Le petit Quevilly, France, 76140
        • Boehringer Ingelheim Investigational Site
      • Lille, France, 59037
        • Hopital Calmette
      • Lyon, France, 69317
        • Hôpital de la Croix-Rousse
      • Lyon, France
        • Hopital Louis Pradel
      • Lyon, France, 69394
        • Hopital Louis Pradel
      • Lyon, France, 69003
        • Boehringer Ingelheim Investigational Site
      • Lyon, France, 69008
        • Boehringer Ingelheim Investigational Site
      • Lyon, France, 69310
        • CH Lyon sud
      • Marseille, France, 13006
        • Hopital Ambroise Pare
      • Marseille, France, 13015
        • Hopital Nord
      • Marseille, France, 13006
        • Boehringer Ingelheim Investigational Site
      • Martigues, France, 13500
        • CHG
      • Metz, France, 57000
        • Boehringer Ingelheim Investigational Site
      • Metz, France, 57038
        • Hôpital N.D. bon Secours
      • Montpellier, France, 34000
        • Service des maladies respiratoires
      • Montpellier Cedex 5, France, 34295
        • Centre Hospitalier Universitaire Arnaud de Villeneuve
      • Ollioules, France, 83192
        • Polyclinique les Fleurs
      • Paris, France, 75004
        • Hôpital Hotel Dieu
      • Paris, France, 75012
        • Hopital St Antoine
      • Paris, France, 75013
        • CTAR
      • Paris cedex 14, France, 75679
        • Hopital Cochin
      • Paris cedex 14, France, 75674
        • Fondation Saint Joseph
      • Paris cedex 18, France, 75877
        • Hopital Bichat-Claude Bernard
      • Paris cedex 20, France, 75970
        • Hopital Tenon
      • Reims, France, 51100
        • Groupe Médical Saint Rémi
      • Rouen cedex, France, 76031
        • Hopital Charles Nicolle
      • Rueil Malmaison cedex, France, 92508
        • CHILTERN
      • Saint Denis de la Réunion, France, 97405
        • CHD Félix Guyon
      • Saint Jean, France, 31240
        • Nouvelle Clinique Union et Vaurais
      • Saint-Pierre Cedex, France, 97448
        • Centre Hospitalier Sud-Réunion
      • Salon de Provence, France, 13300
        • Boehringer Ingelheim Investigational Site
      • Saumur, France, 49400
        • Boehringer Ingelheim Investigational Site
      • Strasbourg, France, 67098
        • Hôpital Hautepierre
      • Strasbourg, France, 67000
        • Boehringer Ingelheim Investigational Site
      • Sélestat, France, 67600
        • Boehringer Ingelheim Investigational Site
      • Toulouse, France, 31403
        • CHU Rangueil
      • Toulouse, France, 31059
        • CHU Purpan
      • Toulouse, France, 31300
        • Cabinet Médical
      • Toulouse, France, 31076
        • Cabinet de Pneumologie
      • Toulouse, France, 31400
        • Clinique Saint Jean Lanquedoc
      • Villefranche Sur Saône, France, 69655
        • Centre Hospitalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:

    • Stable moderate to severe airway obstruction
    • Baseline 30 % < FEV1 < 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
    • Baseline FEV1/SVC< 70 %.
  • Smoking history > 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
  • One pack of cigarettes per day for one year.
  • History of exacerbation in the past year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
morning peak expiratory flow rate (PEFR)
Time Frame: 50 weeks
50 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence, severity and duration of exacerbations
Time Frame: 50 weeks
50 weeks
number of patients with one or more exacerbation
Time Frame: 50 weeks
50 weeks
rate of PEFR drops
Time Frame: 50 weeks
50 weeks
number of lost working days
Time Frame: 50 weeks
50 weeks
number of days of hospitalisation
Time Frame: 50 weeks
50 weeks
use of rescue medications, type and duration
Time Frame: 50 weeks
50 weeks
bacterial and viral characterisation of severe exacerbations
Time Frame: 50 weeks
50 weeks
spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)
Time Frame: 50 weeks
50 weeks
plethysmography (RV, TLC) (optional)
Time Frame: 50 weeks
50 weeks
Adverse events, physical examination
Time Frame: 50 weeks
50 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (ACTUAL)

October 1, 2003

Study Completion

October 1, 2003

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (ESTIMATE)

January 10, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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