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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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

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

Evaluation of onset of effect in patients with severe Chronic Obstructive Pulmonary Disease (COPD) treated with Symbicort® compared to Seretide®

Research Site

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.

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.

Age Continuous

Gender, Male/Female

Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.

Peak Expiratory Flow (PEF) 5 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.

PEF Before Morning Dose

PEF 15 Minutes After Morning Dose

PEF Before Evening Dose

Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.

Forced Expiratory Volume in 1 second (FEV1) Before Morning Dose

FEV1 15 Minutes After Morning Dose

FEV1 Before Evening Dose

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 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.

Change in PEF from Before Dose to 15 Minutes After Dose in the Morning

Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning

Change in FEV1 from Before Dose to 15 Minutes After Dose in the Morning

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.

Change in FEV1 from Before Dose to 5 Minutes After Dose at the Clinic

Change in Forced Vital capacity (FVC) from Before Dose to5 Minutes After Dose at the Clinic

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.

Capacity of Daily Living in the Morning (CDLM) (Change from pre to end of treatment)

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 - 6 with 0=worst and 6 = best.

Arms	Assigned Interventions
Experimental: Symbicort Turbuhaler First, then Seretide Diskus Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg	-
Experimental: Seretide Diskus First, then Symbicort Turbuhaler Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg	-

Evaluation of onset of effect in patients with severe Chronic Obstructive Pulmonary Disease (COPD) treated with Symbicort® compared to Seretide® - SPEED

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=390&filename=CSR-D5892C00016.pdf

CSR-D5892C00016.pdf

CSR-D5892C00016.pdf

CSR-D5892C00016.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator