Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD (CODEX)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: budesonide/formoterol Turbuhaler 320/9µg; Drug: formoterol Turbuhaler 9µg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489853

D5892C00014

Eudract No: 2006-006519-60

Details and patient eligibility

About

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

Enrollment: 137 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: Crossover Assignment

Masking: Quadruple Blind

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137 participants in 3 patient groups, including a placebo group

Symbicort then Formoterol then Placebo

Experimental group

Description:

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily

Treatment:

Drug: budesonide/formoterol Turbuhaler 320/9µg

Drug: formoterol Turbuhaler 9µg

Other: Placebo

Formoterol then Symbicort then Placebo

Experimental group

Description:

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily

Treatment:

Drug: budesonide/formoterol Turbuhaler 320/9µg

Drug: formoterol Turbuhaler 9µg

Other: Placebo

Placebo then Formoterol then Symbicort

Placebo Comparator group

Description:

Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily

Treatment:

Drug: budesonide/formoterol Turbuhaler 320/9µg

Drug: formoterol Turbuhaler 9µg

Other: Placebo