Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg; Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542880

D5892C00016

Details and patient eligibility

About

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

Enrollment: 442 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
• FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
• Pre-bronchodilator

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: Triple Blind

---

442 participants in 2 patient groups

Symbicort Turbuhaler First, then Seretide Diskus

Experimental group

Description:

Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg

Treatment:

Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg

Seretide Diskus First, then Symbicort Turbuhaler

Experimental group

Description:

Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg

Treatment:

Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg