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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg; Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

• Registration Number: NCT00542880
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-12
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-04
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Results First Posted: 2012-08-30
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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

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Exclusion Criteria

• Current respiratory tract disorder other than COPD
• History of asthma or rhinitis
• Significant or unstable cardiovascular disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose	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 Outcome Measures

Name	Time	Method
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	The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.
PEF Before Morning Dose	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
PEF 15 Minutes After Morning Dose	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
PEF Before Evening Dose	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
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	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
FEV1 15 Minutes After Morning Dose	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
FEV1 Before Evening Dose	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.
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	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.
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	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
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	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
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	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.
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	The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.
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	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.
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 change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.
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	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Hamilton, United Kingdom