Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Treatments: Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug); Drug: Spiriva (tiotropium bromide 18ug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00496470

Eudract no:2006-006796-21

D5892C00015

Details and patient eligibility

About

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

Enrollment: 660 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN

Exclusion criteria

• Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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660 participants in 2 patient groups

Symbicort+TIO

Active Comparator group

Description:

Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily

Treatment:

Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Spiriva® + Placebo Turbuhaler

Active Comparator group

Description:

Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily

Treatment:

Drug: Spiriva (tiotropium bromide 18ug)