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

Launched by BOEHRINGER INGELHEIM · Jan 9, 2006

Keywords

ClinConnect Summary

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 dail...

Gender

ALL

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.

Trial Officials