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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00542880




Registration number
NCT00542880
Ethics application status
Date submitted
10/10/2007
Date registered
12/10/2007
Date last updated
30/08/2012

Titles & IDs
Public title
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
Scientific 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.
Secondary ID [1] 0 0
D5892C00016
Universal Trial Number (UTN)
Trial acronym
SPEED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Symbicort Turbuhaler (budesonide/formoterol) 320/9 µg
Treatment: Drugs - Seretide Diskus (salmeterol/fluticasone) 50/500 µg

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


Treatment: Drugs: Symbicort Turbuhaler (budesonide/formoterol) 320/9 µg


Treatment: Drugs: Seretide Diskus (salmeterol/fluticasone) 50/500 µg


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Baseline (run-in, and washout) and day 1 of treatment period
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Baseline (run-in, and washout) and day 1 of treatment period
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current respiratory tract disorder other than COPD

- History of asthma or rhinitis

- Significant or unstable cardiovascular disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Concord
Recruitment hospital [2] 0 0
Research Site - Adelaide
Recruitment hospital [3] 0 0
Research Site - Daw Park
Recruitment hospital [4] 0 0
Research Site - Woodville South
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Parkville
Recruitment hospital [7] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment postcode(s) [4] 0 0
- Woodville South
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Tucuman
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma de Bs. As.
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad de Buenos Aires
Country [5] 0 0
Belgium
State/province [5] 0 0
Jambes
Country [6] 0 0
Belgium
State/province [6] 0 0
Malmedy
Country [7] 0 0
Belgium
State/province [7] 0 0
Montigny-le-tilleul
Country [8] 0 0
Brazil
State/province [8] 0 0
Brasil
Country [9] 0 0
Brazil
State/province [9] 0 0
MG
Country [10] 0 0
Brazil
State/province [10] 0 0
PE
Country [11] 0 0
Brazil
State/province [11] 0 0
RJ
Country [12] 0 0
Brazil
State/province [12] 0 0
RS
Country [13] 0 0
Brazil
State/province [13] 0 0
Santa Catarina
Country [14] 0 0
Brazil
State/province [14] 0 0
SP
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio de Janeiro
Country [16] 0 0
Denmark
State/province [16] 0 0
Aalborg
Country [17] 0 0
Denmark
State/province [17] 0 0
Alborg
Country [18] 0 0
Denmark
State/province [18] 0 0
Hellerup
Country [19] 0 0
Denmark
State/province [19] 0 0
Hvidovre
Country [20] 0 0
Denmark
State/province [20] 0 0
Kobenhavn Nv
Country [21] 0 0
Denmark
State/province [21] 0 0
Odense C
Country [22] 0 0
Denmark
State/province [22] 0 0
Rodovre
Country [23] 0 0
Denmark
State/province [23] 0 0
Silkeborg
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Erfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Germany
State/province [27] 0 0
Marburg
Country [28] 0 0
India
State/province [28] 0 0
Andhra Pradesh
Country [29] 0 0
India
State/province [29] 0 0
Karnataka
Country [30] 0 0
India
State/province [30] 0 0
Rajasthan
Country [31] 0 0
India
State/province [31] 0 0
Coimbatore
Country [32] 0 0
India
State/province [32] 0 0
Noida
Country [33] 0 0
Philippines
State/province [33] 0 0
Manila
Country [34] 0 0
Philippines
State/province [34] 0 0
Quezon City
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Kent
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Lanarkshire
Country [37] 0 0
United Kingdom
State/province [37] 0 0
N. Ireland
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Northern Ireland
Country [39] 0 0
United Kingdom
State/province [39] 0 0
South Glamorgan
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Vale of Glamorgan
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Wiltshire
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Airdrie
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Birmingham
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Blantyre
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Bolton
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Carrickfergus
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Chesterfield
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Coventry
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00542880
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tomas Andersson, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications