Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)
July 27, 2012 updated by: AstraZeneca
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.
This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
442
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ciudad Autonoma de Bs. As., Argentina
- Research Site
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Ciudad de Buenos Aires, Argentina
- Research Site
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Buenos Aires
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Monte Grande, Buenos Aires, Argentina
- Research Site
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Quilmes, Buenos Aires, Argentina
- Research Site
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina
- Research Site
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New South Wales
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Concord, New South Wales, Australia
- Research Site
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South Australia
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Adelaide, South Australia, Australia
- Research Site
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Daw Park, South Australia, Australia
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Woodville South, South Australia, Australia
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Victoria
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Western Australia
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Nedlands, Western Australia, Australia
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Jambes, Belgium
- Research Site
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Malmedy, Belgium
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Montigny-le-tilleul, Belgium
- Research Site
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Rio de Janeiro, Brazil
- Research Site
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Brasil
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Porto Alegre, Brasil, Brazil
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MG
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Juiz de Fora, MG, Brazil
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PE
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Recife, PE, Brazil
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RJ
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Rio de Janeiro, RJ, Brazil
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RS
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Porto Alegre, RS, Brazil
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SP
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Santo Andre, SP, Brazil
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Sao Paulo, SP, Brazil
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Santa Catarina
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Florianopolis, Santa Catarina, Brazil
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Aalborg, Denmark
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Alborg, Denmark
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Hellerup, Denmark
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Hvidovre, Denmark
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Kobenhavn Nv, Denmark
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Odense C, Denmark
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Rodovre, Denmark
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Silkeborg, Denmark
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Berlin, Germany
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Erfurt, Germany
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Leipzig, Germany
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Marburg, Germany
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Coimbatore, India
- Research Site
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Noida, India
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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Karnataka
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Bangalore, Karnataka, India
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Rajasthan
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Jaipur, Rajasthan, India
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Manila, Philippines
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Quezon City, Philippines
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Airdrie, United Kingdom
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Birmingham, United Kingdom
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Blantyre, United Kingdom
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Bolton, United Kingdom
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Carrickfergus, United Kingdom
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Chesterfield, United Kingdom
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Coventry, United Kingdom
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Hamilton, United Kingdom
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Kent
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Dartford, Kent, United Kingdom
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Lanarkshire
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Hamilton, Lanarkshire, United Kingdom
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Motherwell, Lanarkshire, United Kingdom
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N. Ireland
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Cookstown, N. Ireland, United Kingdom
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Northern Ireland
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Limavady, Northern Ireland, United Kingdom
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Newtownabbey, Northern Ireland, United Kingdom
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South Glamorgan
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Barry, South Glamorgan, United Kingdom
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Vale of Glamorgan
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Barry, Vale of Glamorgan, United Kingdom
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Wiltshire
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Bradford-on-avon, Wiltshire, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Symbicort Turbuhaler First, then Seretide Diskus
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
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Experimental: Seretide Diskus First, then Symbicort Turbuhaler
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PEF Before Morning Dose
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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PEF 15 Minutes After Morning Dose
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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PEF Before Evening Dose
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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FEV1 15 Minutes After Morning Dose
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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FEV1 Before Evening Dose
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Change in PEF From Before Dose to 5 Minutes After Dose in the Morning
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Change in PEF From Before Dose to 15 Minutes After Dose in the Morning
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic
Time Frame: Baseline (run-in, and washout) and day 1 of treatment period
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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.
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Baseline (run-in, and washout) and day 1 of treatment period
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Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic
Time Frame: Baseline (run-in, and washout) and day 1 of treatment period
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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.
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Baseline (run-in, and washout) and day 1 of treatment period
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Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)
Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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.
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tomas Andersson, MD, AstraZeneca
- Principal Investigator: Martyn R Partridge, MD FRCP, Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
October 10, 2007
First Submitted That Met QC Criteria
October 10, 2007
First Posted (Estimate)
October 12, 2007
Study Record Updates
Last Update Posted (Estimate)
August 30, 2012
Last Update Submitted That Met QC Criteria
July 27, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Sympathomimetics
- Budesonide
- Fluticasone
- Salmeterol Xinafoate
- Fluticasone-Salmeterol Drug Combination
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- D5892C00016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.