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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274014
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • morning peak expiratory flow rate (PEFR) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence, severity and duration of exacerbations [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • number of patients with one or more exacerbation [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • rate of PEFR drops [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • number of lost working days [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • number of days of hospitalisation [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • use of rescue medications, type and duration [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • bacterial and viral characterisation of severe exacerbations [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • plethysmography (RV, TLC) (optional) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • Adverse events, physical examination [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2000
Estimated Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274014

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274014     History of Changes
Other Study ID Numbers: 205.214
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014