NCT02157935

Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease

A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,026 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description

A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD Patients.

Conditions

• COPD Patients

Interventions

Type	Name	Description
DRUG	Symbicort	Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
DRUG	Formoterol turbohaler	Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
OTHER	Placebo for Symbicort pMDI	pMDI, aerosol for oral inhalation, placebo, 120 doses
OTHER	Placebo for Formoterol Turbohaler	PLacebo powder for oral inhalation, 60 doses

Timeline

• Start date: 2014-06-27
• Primary completion: 2016-02-08
• Completion: 2016-02-08
• First posted: 2014-06-06
• Last updated: 2017-11-07
• Results posted: 2017-06-12

Locations

371 sites across 11 countries: United States, Argentina, Bulgaria, Chile, Czechia, Germany, Mexico, Poland, Puerto Rico, South Africa, Spain