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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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
Sex
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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
442
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00542880