Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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®
Query!
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.
Query!
Secondary ID [1]
0
0
D5892C00016
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SPEED
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [1]
0
0
PEF Before Morning Dose
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [2]
0
0
PEF 15 Minutes After Morning Dose
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [3]
0
0
PEF Before Evening Dose
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [4]
0
0
Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [5]
0
0
FEV1 15 Minutes After Morning Dose
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [6]
0
0
FEV1 Before Evening Dose
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [7]
0
0
Change in PEF From Before Dose to 5 Minutes After Dose in the Morning
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [8]
0
0
Change in PEF From Before Dose to 15 Minutes After Dose in the Morning
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [9]
0
0
Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [10]
0
0
Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [11]
0
0
Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline (run-in, and washout) and day 1 of treatment period
Query!
Secondary outcome [12]
0
0
Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline (run-in, and washout) and day 1 of treatment period
Query!
Secondary outcome [13]
0
0
Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [14]
0
0
Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
Secondary outcome [15]
0
0
The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Query!
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
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Current respiratory tract disorder other than COPD
* History of asthma or rhinitis
* Significant or unstable cardiovascular disorder
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
442
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Research Site - Concord
Query!
Recruitment hospital [2]
0
0
Research Site - Adelaide
Query!
Recruitment hospital [3]
0
0
Research Site - Daw Park
Query!
Recruitment hospital [4]
0
0
Research Site - Woodville South
Query!
Recruitment hospital [5]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [6]
0
0
Research Site - Parkville
Query!
Recruitment hospital [7]
0
0
Research Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
- Concord
Query!
Recruitment postcode(s) [2]
0
0
- Adelaide
Query!
Recruitment postcode(s) [3]
0
0
- Daw Park
Query!
Recruitment postcode(s) [4]
0
0
- Woodville South
Query!
Recruitment postcode(s) [5]
0
0
- Melbourne
Query!
Recruitment postcode(s) [6]
0
0
- Parkville
Query!
Recruitment postcode(s) [7]
0
0
- Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Tucuman
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Ciudad Autonoma de Bs. As.
Query!
Country [4]
0
0
Argentina
Query!
State/province [4]
0
0
Ciudad de Buenos Aires
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Jambes
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Malmedy
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Montigny-le-tilleul
Query!
Country [8]
0
0
Brazil
Query!
State/province [8]
0
0
Brasil
Query!
Country [9]
0
0
Brazil
Query!
State/province [9]
0
0
MG
Query!
Country [10]
0
0
Brazil
Query!
State/province [10]
0
0
PE
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
RJ
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
RS
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Santa Catarina
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
SP
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Rio de Janeiro
Query!
Country [16]
0
0
Denmark
Query!
State/province [16]
0
0
Aalborg
Query!
Country [17]
0
0
Denmark
Query!
State/province [17]
0
0
Alborg
Query!
Country [18]
0
0
Denmark
Query!
State/province [18]
0
0
Hellerup
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Hvidovre
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Kobenhavn Nv
Query!
Country [21]
0
0
Denmark
Query!
State/province [21]
0
0
Odense C
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Rodovre
Query!
Country [23]
0
0
Denmark
Query!
State/province [23]
0
0
Silkeborg
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Berlin
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Erfurt
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Leipzig
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Marburg
Query!
Country [28]
0
0
India
Query!
State/province [28]
0
0
Andhra Pradesh
Query!
Country [29]
0
0
India
Query!
State/province [29]
0
0
Karnataka
Query!
Country [30]
0
0
India
Query!
State/province [30]
0
0
Rajasthan
Query!
Country [31]
0
0
India
Query!
State/province [31]
0
0
Coimbatore
Query!
Country [32]
0
0
India
Query!
State/province [32]
0
0
Noida
Query!
Country [33]
0
0
Philippines
Query!
State/province [33]
0
0
Manila
Query!
Country [34]
0
0
Philippines
Query!
State/province [34]
0
0
Quezon City
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
Kent
Query!
Country [36]
0
0
United Kingdom
Query!
State/province [36]
0
0
Lanarkshire
Query!
Country [37]
0
0
United Kingdom
Query!
State/province [37]
0
0
N. Ireland
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Northern Ireland
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
South Glamorgan
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Vale of Glamorgan
Query!
Country [41]
0
0
United Kingdom
Query!
State/province [41]
0
0
Wiltshire
Query!
Country [42]
0
0
United Kingdom
Query!
State/province [42]
0
0
Airdrie
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
Birmingham
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
Blantyre
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
Bolton
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Carrickfergus
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Chesterfield
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
Coventry
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Hamilton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00542880
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Tomas Andersson, MD
Query!
Address
0
0
AstraZeneca
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF