Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients (SUMIRE)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Formoterol (Oxis Turbuhaler); Drug: Budesonide/formoterol (Symbicort Turbuhaler)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069289

D589DC00007

Details and patient eligibility

About

The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.

Enrollment: 1,293 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
• Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
• A smoking history of at least 10 pack years

Exclusion criteria

• History and/or current clinical diagnosis of asthma
• History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,293 participants in 2 patient groups

1

Experimental group

Description:

Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily

Treatment:

Drug: Budesonide/formoterol (Symbicort Turbuhaler)

2

Active Comparator group

Description:

Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily

Treatment:

Drug: Formoterol (Oxis Turbuhaler)