Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
SPEED
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.
1 other identifier
interventional
442
9 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2007
Shorter than P25 for phase_4
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
August 30, 2012
CompletedAugust 30, 2012
July 1, 2012
11 months
October 10, 2007
August 4, 2009
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (2)
Symbicort Turbuhaler First, then Seretide Diskus
EXPERIMENTALSymbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Seretide Diskus First, then Symbicort Turbuhaler
EXPERIMENTALSeretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current respiratory tract disorder other than COPD
- History of asthma or rhinitis
- Significant or unstable cardiovascular disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (59)
Research Site
Monte Grande, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Ciudad Autonoma de Bs. As., Argentina
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Ciudad de Buenos Aires, Argentina
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Concord, New South Wales, Australia
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Adelaide, South Australia, Australia
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Daw Park, South Australia, Australia
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Woodville South, South Australia, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
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Jambes, Belgium, Belgium
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Malmedy, Belgium, Belgium
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Montigny-le-Tilleul, Belgium, Belgium
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Porto Alegre, Brasil, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, Brazil
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Aalborg, Denmark
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Hellerup, Denmark
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Hvidovre, Denmark
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København NV, Denmark
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Odense C, Denmark
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Rødovre Municipality, 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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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Jaipur, Rajasthan, India
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Coimbatore, India
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Noida, India
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Manila, Philippines
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Quezon City, Philippines
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Dartford, Kent, United Kingdom
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Hamilton, Lanarkshire, United Kingdom
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Motherwell, Lanarkshire, United Kingdom
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Cookstown, Northern Ireland, United Kingdom
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Limavady, Northern Ireland, United Kingdom
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Newtownabbey, Northern Ireland, United Kingdom
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Barry, South Glamorgan, United Kingdom
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Barry, Vale of Glamorgan, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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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
Related Publications (1)
Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
PMID: 19897551DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 12, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 30, 2012
Results First Posted
August 30, 2012
Record last verified: 2012-07