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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

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.