Back to resultsEvaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Symbicort, Seretide
Eligibility Criteria
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Symbicort Turbuhaler First, then Seretide Diskus
Seretide Diskus First, then Symbicort Turbuhaler
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542880
Brief Title
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
Acronym
SPEED
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Symbicort, Seretide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symbicort Turbuhaler First, then Seretide Diskus
Arm Type
Experimental
Arm Description
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Arm Title
Seretide Diskus First, then Symbicort Turbuhaler
Arm Type
Experimental
Arm Description
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Intervention Type
Drug
Intervention Name(s)
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Intervention Type
Drug
Intervention Name(s)
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Primary Outcome Measure Information:
Title
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary Outcome Measure Information:
Title
PEF Before Morning Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
PEF 15 Minutes After Morning Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
PEF Before Evening Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
FEV1 15 Minutes After Morning Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
FEV1 Before Evening Dose
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Change in PEF From Before Dose to 5 Minutes After Dose in the Morning
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Change in PEF From Before Dose to 15 Minutes After Dose in the Morning
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic
Description
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.
Time Frame
Baseline (run-in, and washout) and day 1 of treatment period
Title
Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic
Description
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.
Time Frame
Baseline (run-in, and washout) and day 1 of treatment period
Title
Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Title
The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)
Description
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.
Time Frame
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Andersson, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martyn R Partridge, MD FRCP
Organizational Affiliation
Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Monte Grande
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
State/Province
Tucuman
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma de Bs. As.
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Jambes
Country
Belgium
Facility Name
Research Site
City
Malmedy
Country
Belgium
Facility Name
Research Site
City
Montigny-le-tilleul
Country
Belgium
Facility Name
Research Site
City
Porto Alegre
State/Province
Brasil
Country
Brazil
Facility Name
Research Site
City
Juiz de Fora
State/Province
MG
Country
Brazil
Facility Name
Research Site
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Research Site
City
Florianopolis
State/Province
Santa Catarina
Country
Brazil
Facility Name
Research Site
City
Santo Andre
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Alborg
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
Kobenhavn Nv
Country
Denmark
Facility Name
Research Site
City
Odense C
Country
Denmark
Facility Name
Research Site
City
Rodovre
Country
Denmark
Facility Name
Research Site
City
Silkeborg
Country
Denmark
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Erfurt
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Research Site
City
Coimbatore
Country
India
Facility Name
Research Site
City
Noida
Country
India
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Dartford
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Hamilton
State/Province
Lanarkshire
Country
United Kingdom
Facility Name
Research Site
City
Motherwell
State/Province
Lanarkshire
Country
United Kingdom
Facility Name
Research Site
City
Cookstown
State/Province
N. Ireland
Country
United Kingdom
Facility Name
Research Site
City
Limavady
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Research Site
City
Newtownabbey
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Research Site
City
Barry
State/Province
South Glamorgan
Country
United Kingdom
Facility Name
Research Site
City
Barry
State/Province
Vale of Glamorgan
Country
United Kingdom
Facility Name
Research Site
City
Bradford-on-avon
State/Province
Wiltshire
Country
United Kingdom
Facility Name
Research Site
City
Airdrie
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Blantyre
Country
United Kingdom
Facility Name
Research Site
City
Bolton
Country
United Kingdom
Facility Name
Research Site
City
Carrickfergus
Country
United Kingdom
Facility Name
Research Site
City
Chesterfield
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Hamilton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19897551
Citation
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.
Results Reference
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Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
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