Status:
COMPLETED
Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
41+ years
Phase:
PHASE3
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...
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 (PE...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2003
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00274014
Start Date
October 1 2000
End Date
October 1 2003
Last Update
November 1 2013
Active Locations (55)
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1
Clinique Saint Sauveur
Angers, France, 49000
2
Boehringer Ingelheim Investigational Site
Annecy, France, 74000
3
Clinique la Casamance
Aubagne, France, 13675
4
Boehringer Ingelheim Investigational Site
Avrillé, France, 49240