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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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®
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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.
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Secondary ID [1]
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D5892C00016
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Universal Trial Number (UTN)
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Trial acronym
SPEED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [1]
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PEF Before Morning Dose
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [2]
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PEF 15 Minutes After Morning Dose
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [3]
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PEF Before Evening Dose
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [4]
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Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [5]
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FEV1 15 Minutes After Morning Dose
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [6]
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FEV1 Before Evening Dose
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [7]
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Change in PEF From Before Dose to 5 Minutes After Dose in the Morning
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [8]
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Change in PEF From Before Dose to 15 Minutes After Dose in the Morning
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [9]
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Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [10]
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Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [11]
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Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline (run-in, and washout) and day 1 of treatment period
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Secondary outcome [12]
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Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline (run-in, and washout) and day 1 of treatment period
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Secondary outcome [13]
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Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [14]
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Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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Secondary outcome [15]
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The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
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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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current respiratory tract disorder other than COPD
- History of asthma or rhinitis
- Significant or unstable cardiovascular disorder
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2008
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Sample size
Target
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Accrual to date
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Final
442
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Concord
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Recruitment hospital [2]
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Research Site - Adelaide
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Recruitment hospital [3]
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Research Site - Daw Park
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Recruitment hospital [4]
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Research Site - Woodville South
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Recruitment hospital [5]
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Research Site - Melbourne
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Recruitment hospital [6]
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Research Site - Parkville
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Recruitment hospital [7]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment postcode(s) [3]
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- Daw Park
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Recruitment postcode(s) [4]
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- Woodville South
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Recruitment postcode(s) [5]
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- Melbourne
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment postcode(s) [7]
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- Nedlands
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Tucuman
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Country [3]
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Argentina
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State/province [3]
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Ciudad Autonoma de Bs. As.
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Country [4]
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Argentina
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State/province [4]
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Ciudad de Buenos Aires
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Country [5]
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Belgium
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State/province [5]
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Jambes
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Country [6]
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Belgium
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State/province [6]
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Malmedy
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Country [7]
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Belgium
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State/province [7]
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Montigny-le-tilleul
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Country [8]
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Brazil
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State/province [8]
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Brasil
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Country [9]
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Brazil
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State/province [9]
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MG
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Country [10]
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Brazil
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State/province [10]
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PE
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Country [11]
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Brazil
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State/province [11]
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RJ
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Country [12]
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Brazil
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State/province [12]
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RS
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Country [13]
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Brazil
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State/province [13]
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Santa Catarina
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Country [14]
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Brazil
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State/province [14]
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SP
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Country [15]
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Brazil
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State/province [15]
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Rio de Janeiro
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Country [16]
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Denmark
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State/province [16]
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Aalborg
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Denmark
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Alborg
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Country [18]
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Denmark
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State/province [18]
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Hellerup
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Country [19]
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Denmark
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State/province [19]
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Hvidovre
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Country [20]
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Denmark
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State/province [20]
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Kobenhavn Nv
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Country [21]
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Denmark
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State/province [21]
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Odense C
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Country [22]
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Denmark
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State/province [22]
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Rodovre
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Country [23]
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Denmark
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State/province [23]
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Silkeborg
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Country [24]
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Germany
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State/province [24]
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Berlin
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Country [25]
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Germany
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State/province [25]
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Erfurt
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Country [26]
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Germany
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State/province [26]
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Leipzig
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Germany
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State/province [27]
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Marburg
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Country [28]
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India
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State/province [28]
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Andhra Pradesh
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Country [29]
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India
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State/province [29]
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Karnataka
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Country [30]
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India
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State/province [30]
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Rajasthan
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India
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State/province [31]
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Coimbatore
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Country [32]
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India
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State/province [32]
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Noida
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Country [33]
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Philippines
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State/province [33]
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Manila
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Country [34]
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Philippines
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State/province [34]
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Quezon City
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Country [35]
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United Kingdom
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State/province [35]
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Kent
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Country [36]
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United Kingdom
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State/province [36]
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Lanarkshire
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Country [37]
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United Kingdom
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State/province [37]
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N. Ireland
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Country [38]
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United Kingdom
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State/province [38]
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Northern Ireland
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Country [39]
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United Kingdom
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State/province [39]
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South Glamorgan
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Country [40]
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United Kingdom
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State/province [40]
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Vale of Glamorgan
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Country [41]
0
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United Kingdom
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State/province [41]
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Wiltshire
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Country [42]
0
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United Kingdom
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State/province [42]
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Airdrie
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Country [43]
0
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United Kingdom
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State/province [43]
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Birmingham
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Country [44]
0
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United Kingdom
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State/province [44]
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Blantyre
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Country [45]
0
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United Kingdom
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State/province [45]
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Bolton
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Country [46]
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United Kingdom
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State/province [46]
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Carrickfergus
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Country [47]
0
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United Kingdom
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State/province [47]
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Chesterfield
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Country [48]
0
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United Kingdom
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State/province [48]
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Coventry
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Country [49]
0
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United Kingdom
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State/province [49]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00542880
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tomas Andersson, MD
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00542880
Download to PDF