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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/NCT00479739




Registration number
NCT00479739
Ethics application status
Date submitted
25/05/2007
Date registered
28/05/2007
Date last updated
15/09/2016

Titles & IDs
Public title
CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE® Inhaler With An Adjustable Maintenance Dose Of SYMBICORT® Inhaler. SERETIDE® Inhaler is a Trademark of GSK Group of Companies. SYMBICORT® Inhaler is a Trademark of Astra Zeneca.
Scientific title
Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics
Secondary ID [1] 0 0
SAM40056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Salmeterol/fluticasone propionate or formoterol/budesonide

Experimental: Arm 1 -


Treatment: Drugs: Salmeterol/fluticasone propionate or formoterol/budesonide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean percentage of symptom-free days over a 52-week treatment period
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Mean percentage of rescue-free days Daily asthma symptom scores Daily rescue usage Mean morning peak flow Percentage of nights awoken due to asthma Rate of exacerbations Airway hyper-responsiveness(PC20 AMP)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Documented clinical history of asthma

- Forced expiratory volume in 1 second between 60% and 90% of predicted

- Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of
beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS
alone at a dose equivalent to >500 to 1000mcg daily of BDP daily
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lower respiratory tract infection within 1 month of study entry

- Use of systemic corticosteroids within 1 month of study entry

- Smoking history of 10 pack years or more Changes in regular asthma therapy within 12
weeks of study entry

- Any significant disorder that in the investigator's opinion might put the patient at
risk or influence the study outcomes

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 analysing the results/data
Intervention assignment
Parallel
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
1/11/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2004
Sample size
Target
Accrual to date
Final
700
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Balmain
Recruitment hospital [2] 0 0
GSK Investigational Site - Brisbane
Recruitment hospital [3] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [4] 0 0
GSK Investigational Site - Toorak Gardens
Recruitment postcode(s) [1] 0 0
2041 - Balmain
Recruitment postcode(s) [2] 0 0
4077 - Brisbane
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
5065 - Toorak Gardens
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Belgium
State/province [4] 0 0
Ath
Country [5] 0 0
Belgium
State/province [5] 0 0
Gilly
Country [6] 0 0
Belgium
State/province [6] 0 0
Hornu
Country [7] 0 0
Belgium
State/province [7] 0 0
Leopoldsburg
Country [8] 0 0
Belgium
State/province [8] 0 0
Oostham
Country [9] 0 0
Belgium
State/province [9] 0 0
Tessenderlo
Country [10] 0 0
Belgium
State/province [10] 0 0
Tienen
Country [11] 0 0
Bulgaria
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Plovdiv
Country [12] 0 0
Bulgaria
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Rousse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
New Brunswick
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Estonia
State/province [21] 0 0
Kohtal-Jdrve
Country [22] 0 0
Estonia
State/province [22] 0 0
Tallinn
Country [23] 0 0
Estonia
State/province [23] 0 0
Tartu
Country [24] 0 0
Finland
State/province [24] 0 0
Joensuu
Country [25] 0 0
Finland
State/province [25] 0 0
Lahti
Country [26] 0 0
Finland
State/province [26] 0 0
Pietarsaari
Country [27] 0 0
Finland
State/province [27] 0 0
Raahe
Country [28] 0 0
Finland
State/province [28] 0 0
Tampere
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Finland
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Varkaus
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Berlin
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Ireland
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Blackpool, Cork
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Ireland
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Dublin
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Ireland
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Galway
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Ireland
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Kilkenny
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Ireland
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Lifford
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Ireland
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Tallaght, Dublin
Country [40] 0 0
Latvia
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Limbazi
Country [41] 0 0
Latvia
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Riga
Country [42] 0 0
Latvia
State/province [42] 0 0
Valmiera
Country [43] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [43] 0 0
Skopje
Country [44] 0 0
Netherlands
State/province [44] 0 0
's-HERTOGENBOSCH
Country [45] 0 0
Netherlands
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Almelo
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Netherlands
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Bennebroek
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Netherlands
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Eindhoven
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Netherlands
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Geldermalsen
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Netherlands
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Heerlen
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Netherlands
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Helmond
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Netherlands
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Losser
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Netherlands
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Made
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Netherlands
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Rotterdam
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Netherlands
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Spijkenisse
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Netherlands
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Utrecht
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Netherlands
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Voerendaal
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New Zealand
State/province [57] 0 0
Auckland
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New Zealand
State/province [58] 0 0
Christchurch Hospital
Country [59] 0 0
Spain
State/province [59] 0 0
Alcorcon
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
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Galdakano
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Spain
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La Coruña
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Spain
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Las Palmas
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Valencia
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United Kingdom
State/province [68] 0 0
Cambridgeshire
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United Kingdom
State/province [69] 0 0
Essex
Country [70] 0 0
United Kingdom
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Glamorgan
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United Kingdom
State/province [71] 0 0
Lancashire
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Fleetwood

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

Ethics approval
Ethics application status

Summary
Brief summary
To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of
formoterol/budesonide where the dose is adjusted according to a physician-guided
self-management plan
Trial website
https://clinicaltrials.gov/ct2/show/NCT00479739
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00479739