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

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

Official Title
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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.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
* Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symbicort Turbuhaler First, then Seretide Diskus<br>Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg | Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg<br> <br> Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg<br> <br> |
| Experimental: Seretide Diskus First, then Symbicort Turbuhaler<br>Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg | Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg<br> <br> Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose | 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. | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEF Before Morning Dose | 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. | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days | 
| PEF 15 Minutes After Morning Dose | 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. | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days | 
| PEF Before Evening Dose | 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. | 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 | 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. | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days | 
| FEV1 15 Minutes After Morning Dose | 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. | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days | 
| FEV1 Before Evening Dose | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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) | 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. | 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) | 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. | 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) | 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. | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Symbicort, Seretide