Clinical Trials/NCT00542880

NCT00542880

Completed

Phase 4

A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbuhaler® 320/9 μg, Compared With Seretide® Diskus® 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.

AstraZeneca1 site in 1 country442 target enrollmentSeptember 2007

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsSymbicort Turbuhaler (budesonide/formoterol) 320/9 μg Seretide Diskus (salmeterol/fluticasone) 50/500 μg

DrugsSymbicort Turbuhaler (budesonide/formoterol) 320/9 μg Seretide Diskus (salmeterol/fluticasone) 50/500 μg

Overview

Phase: Phase 4
Intervention: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: AstraZeneca
Enrollment: 442
Locations: 1
Primary Endpoint: Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

August 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Symbicort Turbuhaler First, then Seretide Diskus

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

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

Symbicort Turbuhaler First, then Seretide Diskus

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

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

Seretide Diskus First, then Symbicort Turbuhaler

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

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

Seretide Diskus First, then Symbicort Turbuhaler

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

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

Outcomes

Primary Outcomes

Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose

Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.

Secondary Outcomes

PEF Before Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
PEF 15 Minutes After Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
PEF Before Evening Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
FEV1 15 Minutes After Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
FEV1 Before Evening Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Change in PEF From Before Dose to 5 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Change in PEF From Before Dose to 15 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic(Baseline (run-in, and washout) and day 1 of treatment period)
Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic(Baseline (run-in, and washout) and day 1 of treatment period)
Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)