A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients

NCT00206154 Phase 3 COMPLETED

The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	1500
Start date	2005-04
Completion	2006-12

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• Budesonide/formoterol pMDI
• Budesonide pMDI
• Formoterol Turbuhaler

Primary outcomes

• Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Countries

United States, Czechia, Netherlands, Poland, South Africa