Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
NCT ID: NCT00274014
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2000-10-31
2003-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tiotropium
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
41 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BI France S.A.S.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique Saint Sauveur
Angers, , France
Boehringer Ingelheim Investigational Site
Annecy, , France
Clinique la Casamance
Aubagne, , France
Boehringer Ingelheim Investigational Site
Avrillé, , France
Hôpital
Bois-Guillaume, , France
GPL
Caluire-et-Cuire, , France
Boehringer Ingelheim Investigational Site
Châlons-en-Champagne, , France
CH Cholet
Cholet, , France
Boehringer Ingelheim Investigational Site
Cholet, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Clinique des Cèdres
Cornebarrieu, , France
Clinique Saint Vincent
Épernay, , France
Centre Hospitalier Auban Moet
Épernay, , France
Boehringer Ingelheim Investigational Site
Le Blanc-Mesnil, , France
Boehringer Ingelheim Investigational Site
Le Petit-Quevilly, , France
Hôpital Calmette
Lille, , France
Boehringer Ingelheim Investigational Site
Lyon, , France
Boehringer Ingelheim Investigational Site
Lyon, , France
CH Lyon Sud
Lyon, , France
Hôpital de la Croix-Rousse
Lyon, , France
Hôpital Louis Pradel
Lyon, , France
Hôpital Louis Pradel
Lyon, , France
Boehringer Ingelheim Investigational Site
Marseille, , France
Hôpital Ambroise Paré
Marseille, , France
Hôpital Nord
Marseille, , France
CHG
Martigues, , France
Boehringer Ingelheim Investigational Site
Metz, , France
Hôpital N.D. bon Secours
Metz, , France
Service des maladies respiratoires
Montpellier, , France
Centre Hospitalier Universitaire Arnaud de Villeneuve
Montpellier, , France
Polyclinique Les Fleurs
Ollioules, , France
Hôpital Hôtel Dieu
Paris, , France
Hôpital St Antoine
Paris, , France
CTAR
Paris, , France
Fondation Saint Joseph
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Bichat-Claude Bernard
Paris, , France
Hôpital Tenon
Paris, , France
Groupe Médical Saint Rémi
Reims, , France
Hôpital Charles Nicolle
Rouen, , France
CHILTERN
Rueil-Malmaison, , France
CHD Félix Guyon
Saint Denis de La Réunion, , France
Nouvelle Clinique Union et Vaurais
Saint-Jean, , France
Centre Hospitalier Sud-Réunion
Saint-Pierre, , France
Boehringer Ingelheim Investigational Site
Salon-de-Provence, , France
Boehringer Ingelheim Investigational Site
Saumur, , France
Boehringer Ingelheim Investigational Site
Sélestat, , France
Boehringer Ingelheim Investigational Site
Strasbourg, , France
Hôpital Hautepierre
Strasbourg, , France
CHU Purpan
Toulouse, , France
Cabinet de Pneumologie
Toulouse, , France
Cabinet Médical
Toulouse, , France
Clinique Saint Jean Lanquedoc
Toulouse, , France
CHU Rangueil
Toulouse, , France
Centre Hospitalier
Villefranche-sur-Saône, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
205.214
Identifier Type: -
Identifier Source: org_study_id