A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease

NCT00424528 Phase 4 COMPLETED Results posted

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	235
Start date	2006-12
Completion	2007-10

Conditions

• Chronic Obstructive Pulmonary Disease
• Bronchitis
• Emphysema

Interventions

• Arformoterol Tartrate Inhalation Solution
• Tiotropium
• Arformoterol and Tiotropium
• Placebo

Primary outcomes

• Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) — 24 hours following two weeks of dosing.

Countries

United States