Study in Subjects Greater Than 40 Years of Age With COPD

Dey Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: formoterol fumarate inhalation solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507234

201-080

Details and patient eligibility

About

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Enrollment: 128 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical diagnosis of COPD
• Current or prior history of cigarette smoking

Exclusion criteria

• Medical diagnosis of asthma
• Significant condition or disease other than COPD

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind