Clinical trial NCT00274014: Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: morning peak expiratory flow rate (PEFR)
timeFrame: 50 weeks
Secondary outcomes:
measure: incidence, severity and duration of exacerbations
timeFrame: 50 weeks
measure: number of patients with one or more exacerbation
timeFrame: 50 weeks
measure: rate of PEFR drops
timeFrame: 50 weeks
measure: number of lost working days
timeFrame: 50 weeks
measure: number of days of hospitalisation
timeFrame: 50 weeks
measure: use of rescue medications, type and duration
timeFrame: 50 weeks
measure: bacterial and viral characterisation of severe exacerbations
timeFrame: 50 weeks
measure: spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)
timeFrame: 50 weeks
measure: plethysmography (RV, TLC) (optional)
timeFrame: 50 weeks
measure: Adverse events, physical examination
timeFrame: 50 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Clinique Saint Sauveur
city: Annecy
country: France
facility: Boehringer Ingelheim Investigational Site
city: Aubagne
country: France
facility: Clinique la Casamance
city: Avrille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Bois Guillaume cedex
country: France
facility: Hôpital
city: Caluire
country: France
facility: GPL
city: Cholet
country: France
facility: CH Cholet
city: Cholet
country: France
facility: Boehringer Ingelheim Investigational Site
city: Châlons en Champagne
country: France
facility: Boehringer Ingelheim Investigational Site
city: Clermont-Ferrand cedex 1
country: France
facility: Hôpital Gabriel Montpied
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Epernay
country: France
facility: Clinique Saint Vincent
city: Epernay
country: France
facility: Centre Hospitalier Auban Moet
city: Le Blanc Mesnil cedex
country: France
facility: Boehringer Ingelheim Investigational Site
city: Le petit Quevilly
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: Hôpital Calmette
city: Lyon
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: CH Lyon Sud
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Marseille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: Hôpital Ambroise Paré
city: Marseille
country: France
facility: Hôpital Nord
city: Martigues
country: France
facility: CHG
city: Metz
country: France
facility: Boehringer Ingelheim Investigational Site
city: Metz
country: France
facility: Hôpital N.D. bon Secours
city: Montpellier Cedex 5
country: France
facility: Centre Hospitalier Universitaire Arnaud de Villeneuve
city: Montpellier
country: France
facility: Service des maladies respiratoires
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Paris cedex 14
country: France
facility: Fondation Saint Joseph
city: Paris cedex 14
country: France
facility: Hôpital Cochin
city: Paris cedex 18
country: France
facility: Hôpital Bichat-Claude Bernard
city: Paris cedex 20
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Hôtel Dieu
city: Paris
country: France
facility: Hôpital St Antoine
city: Paris
country: France
facility: CTAR
city: Reims
country: France
facility: Groupe Médical Saint Rémi
city: Rouen cedex
country: France
facility: Hôpital Charles Nicolle
city: Rueil Malmaison cedex
country: France
facility: CHILTERN
city: Saint Denis de la Réunion
country: France
facility: CHD Félix Guyon
city: Saint Jean
country: France
facility: Nouvelle Clinique Union et Vaurais
city: Saint-Pierre Cedex
country: France
facility: Centre Hospitalier Sud-Réunion
city: Salon de Provence
country: France
facility: Boehringer Ingelheim Investigational Site
city: Saumur
country: France
facility: Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Sélestat
country: France
facility: Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: CHU Purpan
city: Toulouse
country: France
facility: Cabinet de Pneumologie
city: Toulouse
country: France
facility: Cabinet Médical
city: Toulouse
country: France
facility: Clinique Saint Jean Lanquedoc
city: Toulouse
country: France
facility: CHU Rangueil
city: Villefranche Sur Saône
country: France
facility: Centre Hospitalier
Study officials:
affiliation: BI France S.A.S.
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: