Conditions: COPD Patients
Keywords: COPD, turbuhaler, pMDI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2026
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation arm 2: Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation

Interventions: intervention 1: Symbicort intervention 2: Formoterol turbohaler intervention 3: Placebo for Symbicort pMDI intervention 4: Placebo for Formoterol Turbohaler
Intervention descriptions: intervention 1: Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses intervention 2: Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses intervention 3: pMDI, aerosol for oral inhalation, placebo, 120 doses intervention 4: PLacebo powder for oral inhalation, 60 doses

Protocol document: