A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.

Sosei33 sites in 4 countries300 target enrollmentOctober 2005

ConditionsCOPD

DrugsAD 237

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COPD
Sponsor: Sosei
Enrollment: 300
Locations: 33
Primary Endpoint: Pulmonary function
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sosei

Eligibility Criteria

Inclusion Criteria

•Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.
•Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.
•Pre-bronchodilator FEV1/FVC ratio of less than 70%.
•Current or ex-smokers with a smoking history of at least 10 pack years.

Exclusion Criteria

•History of asthma, atopy or allergic rhinitis.
•Other serious respiratory or other medical conditions which may interfere with the outcome of the study.