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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274014
• Other study ID #: 205.214
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: October 31, 2013
• Start date: October 2000
• Est. completion date: October 2003

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium

Locations

Country	Name	City	State
France	Clinique Saint Sauveur	Angers
France	Boehringer Ingelheim Investigational Site	Annecy
France	Clinique la Casamance	Aubagne
France	Boehringer Ingelheim Investigational Site	Avrille
France	Hôpital	Bois Guillaume cedex
France	GPL	Caluire
France	Boehringer Ingelheim Investigational Site	Châlons en Champagne
France	Boehringer Ingelheim Investigational Site	Cholet
France	CH Cholet	Cholet
France	Hôpital Gabriel Montpied	Clermont-Ferrand cedex 1
France	Clinique des Cèdres	Cornebarrieu
France	Centre Hospitalier Auban Moet	Epernay
France	Clinique Saint Vincent	Epernay
France	Boehringer Ingelheim Investigational Site	Le Blanc Mesnil cedex
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 Cedex 5
France	Polyclinique Les Fleurs	Ollioules
France	CTAR	Paris
France	Hôpital Hôtel Dieu	Paris
France	Hôpital St Antoine	Paris
France	Fondation Saint Joseph	Paris cedex 14
France	Hôpital Cochin	Paris cedex 14
France	Hôpital Bichat-Claude Bernard	Paris cedex 18
France	Hôpital Tenon	Paris cedex 20
France	Groupe Médical Saint Rémi	Reims
France	Hôpital Charles Nicolle	Rouen cedex
France	CHILTERN	Rueil Malmaison cedex
France	CHD Félix Guyon	Saint Denis de la Réunion
France	Nouvelle Clinique Union et Vaurais	Saint Jean
France	Centre Hospitalier Sud-Réunion	Saint-Pierre Cedex
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	Cabinet de Pneumologie	Toulouse
France	Cabinet Médical	Toulouse
France	CHU Purpan	Toulouse
France	CHU Rangueil	Toulouse
France	Clinique Saint Jean Lanquedoc	Toulouse
France	Centre Hospitalier	Villefranche Sur Saône

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morning peak expiratory flow rate (PEFR)		50 weeks	No
Secondary	incidence, severity and duration of exacerbations		50 weeks	No
Secondary	number of patients with one or more exacerbation		50 weeks	No
Secondary	rate of PEFR drops		50 weeks	No
Secondary	number of lost working days		50 weeks	No
Secondary	number of days of hospitalisation		50 weeks	No
Secondary	use of rescue medications, type and duration		50 weeks	No
Secondary	bacterial and viral characterisation of severe exacerbations		50 weeks	No
Secondary	spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)		50 weeks	No
Secondary	plethysmography (RV, TLC) (optional)		50 weeks	No
Secondary	Adverse events, physical examination		50 weeks	No

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