Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
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.
1 other identifier
interventional
1,000
1 country
55
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2000
Typical duration for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2006
CompletedFirst Posted
Study publicly available on registry
January 10, 2006
CompletedNovember 1, 2013
October 1, 2013
3 years
January 9, 2006
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
morning peak expiratory flow rate (PEFR)
50 weeks
Secondary Outcomes (10)
incidence, severity and duration of exacerbations
50 weeks
number of patients with one or more exacerbation
50 weeks
rate of PEFR drops
50 weeks
number of lost working days
50 weeks
number of days of hospitalisation
50 weeks
- +5 more secondary outcomes
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (55)
Clinique Saint Sauveur
Angers, 49000, France
Boehringer Ingelheim Investigational Site
Annecy, 74000, France
Clinique la Casamance
Aubagne, 13675, France
Boehringer Ingelheim Investigational Site
Avrillé, 49240, France
Hôpital
Bois-Guillaume, 76233, France
GPL
Caluire-et-Cuire, 69300, France
Boehringer Ingelheim Investigational Site
Châlons-en-Champagne, 51000, France
CH Cholet
Cholet, 49235, France
Boehringer Ingelheim Investigational Site
Cholet, 49300, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003, France
Clinique des Cèdres
Cornebarrieu, 31700, France
Clinique Saint Vincent
Épernay, 51200, France
Centre Hospitalier Auban Moet
Épernay, 51201, France
Boehringer Ingelheim Investigational Site
Le Blanc-Mesnil, 93156, France
Boehringer Ingelheim Investigational Site
Le Petit-Quevilly, 76140, France
Hôpital Calmette
Lille, 59037, France
Boehringer Ingelheim Investigational Site
Lyon, 69003, France
Boehringer Ingelheim Investigational Site
Lyon, 69008, France
CH Lyon Sud
Lyon, 69310, France
Hôpital de la Croix-Rousse
Lyon, 69317, France
Hôpital Louis Pradel
Lyon, 69394, France
Hôpital Louis Pradel
Lyon, France
Boehringer Ingelheim Investigational Site
Marseille, 13006, France
Hôpital Ambroise Paré
Marseille, 13006, France
Hôpital Nord
Marseille, 13015, France
CHG
Martigues, 13500, France
Boehringer Ingelheim Investigational Site
Metz, 57000, France
Hôpital N.D. bon Secours
Metz, 57038, France
Service des maladies respiratoires
Montpellier, 34000, France
Centre Hospitalier Universitaire Arnaud de Villeneuve
Montpellier, 34295, France
Polyclinique Les Fleurs
Ollioules, 83192, France
Hôpital Hôtel Dieu
Paris, 75004, France
Hôpital St Antoine
Paris, 75012, France
CTAR
Paris, 75013, France
Fondation Saint Joseph
Paris, 75674, France
Hôpital Cochin
Paris, 75679, France
Hôpital Bichat-Claude Bernard
Paris, 75877, France
Hôpital Tenon
Paris, 75970, France
Groupe Médical Saint Rémi
Reims, 51100, France
Hôpital Charles Nicolle
Rouen, 76031, France
CHILTERN
Rueil-Malmaison, 92508, France
CHD Félix Guyon
Saint Denis de La Réunion, 97405, France
Nouvelle Clinique Union et Vaurais
Saint-Jean, 31240, France
Centre Hospitalier Sud-Réunion
Saint-Pierre, 97448, France
Boehringer Ingelheim Investigational Site
Salon-de-Provence, 13300, France
Boehringer Ingelheim Investigational Site
Saumur, 49400, France
Boehringer Ingelheim Investigational Site
Sélestat, 67600, France
Boehringer Ingelheim Investigational Site
Strasbourg, 67000, France
Hôpital Hautepierre
Strasbourg, 67098, France
CHU Purpan
Toulouse, 31059, France
Cabinet de Pneumologie
Toulouse, 31076, France
Cabinet Médical
Toulouse, 31300, France
Clinique Saint Jean Lanquedoc
Toulouse, 31400, France
CHU Rangueil
Toulouse, 31403, France
Centre Hospitalier
Villefranche-sur-Saône, 69655, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
BI France S.A.S.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 9, 2006
First Posted
January 10, 2006
Study Start
October 1, 2000
Primary Completion
October 1, 2003
Study Completion
October 1, 2003
Last Updated
November 1, 2013
Record last verified: 2013-10