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AzTrials

AsthmaPhase 4NCT00479739

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.

A Phase 4 study testing Salmeterol/fluticasone propionate or formoterol/budesonide in people with Asthma, run by GlaxoSmithKline at 106 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma
What is being tested?
Salmeterol/fluticasone propionate or formoterol/budesonide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
106 sitesin 15 countries
Study dates
Nov 2002to Jul 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

106 sites in 15 countries.

106 sites in 15 countries

Canada13 sites

  • GSK Investigational Site

    Brampton, Ontario, L6Y 2E6

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N1

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Maple Ridge, British Columbia, V2X 2L5

  • GSK Investigational Site

    Mississauga, Ontario, L5A 1N1

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Peterborough, Ontario, K9J 7B3

  • GSK Investigational Site

    Saint John, New Brunswick, E2M 3W5

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 3J5

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Netherlands13 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5211 NL

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Bennebroek, 2121 BB

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Geldermalsen, 4191 AH

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Helmond, 5707 HA

  • GSK Investigational Site

    Losser, 7581 BV

  • GSK Investigational Site

    Made, 4921 BC

  • GSK Investigational Site

    Rotterdam, 3015 GD

  • GSK Investigational Site

    Spijkenisse, 3207 NB

  • GSK Investigational Site

    Utrecht, 2584 CX

  • GSK Investigational Site

    Voerendaal, 6367 ED

Other trials in Netherlands

Germany12 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Berlin, State of Berlin, 10178

  • GSK Investigational Site

    Berlin, State of Berlin, 10717

  • GSK Investigational Site

    Berlin, State of Berlin, 13086

  • GSK Investigational Site

    Berlin, State of Berlin, 13187

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Berlin, State of Berlin, 13597

  • GSK Investigational Site

    Bruchsal, Baden-Wurttemberg, 76646

  • GSK Investigational Site

    Erlangen, Bavaria, 91052

  • GSK Investigational Site

    Lahr, Baden-Wurttemberg, 77933

  • GSK Investigational Site

    Munich, Bavaria, 81677

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

Other trials in Germany

Spain11 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alcorcón, 28922

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08221

  • GSK Investigational Site

    Galdakano, 48960

  • GSK Investigational Site

    Las Palmas, 35020

  • GSK Investigational Site

    Lugo, 27004

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Málaga, 29400

  • GSK Investigational Site

    Valencia, 46017

Other trials in Spain

United Kingdom10 sites

  • GSK Investigational Site

    Barry, Glamorgan, CF63 4HP

  • GSK Investigational Site

    Blackpool, Lancashire, FY1 6JW

  • GSK Investigational Site

    Blackpool, Lancashire, FY4 3AD

  • GSK Investigational Site

    Cambridge, Cambridgeshire, CB3 9HS

  • GSK Investigational Site

    Cardiff, Glamorgan, CF14 9BB

  • GSK Investigational Site

    Cardiff, Glamorgan, CF23 5SY

  • GSK Investigational Site

    Fleetwood, FY7 6HD

  • GSK Investigational Site

    Fleetwood, FY7 7DG

  • GSK Investigational Site

    Manchester, Lancashire, M23 9GP

  • GSK Investigational Site

    Saffron Walden, Essex, CB10 1EJ

Other trials in United Kingdom

Ireland9 sites

  • GSK Investigational Site

    Blackpool, Cork

  • GSK Investigational Site

    Dublin, 22

  • GSK Investigational Site

    Dublin, 6

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dublin

  • GSK Investigational Site

    Galway

  • GSK Investigational Site

    Kilkenny

  • GSK Investigational Site

    Lifford

  • GSK Investigational Site

    Tallaght, Dublin, 24

Other trials in Ireland

Belgium8 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Ath, 7800

  • GSK Investigational Site

    Gilly, 6060

  • GSK Investigational Site

    Hornu, 7301

  • GSK Investigational Site

    Leopoldsburg, 3970

  • GSK Investigational Site

    Oostham, 3945

  • GSK Investigational Site

    Tessenderlo, 3980

  • GSK Investigational Site

    Tienen, 3300

Other trials in Belgium

Finland6 sites

  • GSK Investigational Site

    Jakobstad, 68600

  • GSK Investigational Site

    Joensuu, 80100

  • GSK Investigational Site

    Lahti, 15850

  • GSK Investigational Site

    Raahe, 92100

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Varkaus, 78300

Other trials in Finland

Australia4 sites

  • GSK Investigational Site

    Balmain, New South Wales, 2041

  • GSK Investigational Site

    Brisbane, Queensland, 4077

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Toorak Gardens, South Australia, 5065

Other trials in Australia

Austria4 sites

  • GSK Investigational Site

    Linz, A-4020

  • GSK Investigational Site

    Vienna, A-1030

  • GSK Investigational Site

    Vienna, A-1120

  • GSK Investigational Site

    Vienna, A-1210

Other trials in Austria

Bulgaria4 sites

  • GSK Investigational Site

    Plovdiv

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Estonia4 sites

  • GSK Investigational Site

    Kohtal-Jdrve, 31 025

  • GSK Investigational Site

    Tallinn, 10120

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Latvia4 sites

  • GSK Investigational Site

    Limbaži, LV 4000

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV 1035

  • GSK Investigational Site

    Valmiera, LV 4201

Other trials in Latvia

New Zealand3 sites

  • GSK Investigational Site

    Auckland, 1001

  • GSK Investigational Site

    Auckland, 1701

  • GSK Investigational Site

    Christchurch Hospital, 8001

Other trials in New Zealand

North Macedonia1 site

  • GSK Investigational Site

    Skopje, 9100

Other trials in North Macedonia

About this study

Official 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

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

Read the detailed description

A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics

Conditions
Asthma
Being tested
Salmeterol/fluticasone propionate or formoterol/budesonide
Keywords
formoterol/budesonide, exacerbations, Salmeterol/fluticasone propionate, adjustable maintenance dosing, asthma control
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salmeterol/fluticasone propionate or formoterol/budesonideDrug

Study groups in NCT00479739
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Salmeterol/fluticasone propionate or formoterol/budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean percentage of symptom-free days over a 52-week treatment period

Secondary outcomes (1)

  1. 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2007 (estimated)
  2. Study startNov 2002
  3. Primary completionJul 2004
  4. Study completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00479739
Sponsor's protocol ID
SAM40056
Status last verified
Sep 2016
First submitted
25 May 2007
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Boulet LP, Fitzgerald M, Pieters R. The CONCEPT study: comparative influence of two treatment strategies on airway response to AMP. European Respiratory Journal Supplement 2005; 26: 429.

  • FitzGerald JM, Boulet LP, Follows RM. The CONCEPT trial: a 1-year, multicenter, randomized,double-blind, double-dummy comparison of a stable dosing regimen of salmeterol/fluticasone propionate with an adjustable maintenance dosing regimen of formoterol/budesonide in adults with persistent asthma. Clin Ther. 2005 Apr;27(4):393-406. doi: 10.1016/j.clinthera.2005.03.006.

    PubMed 15922813

  • Fitzgerald M, Boulet LP, Pieters WR. Improved control of symptoms and exacerbations with stable dose treatment with salmeterol/fluticasone propionate compared with adjustable maintenance dosing with formoterol/budesonide. European Respiratory Journal Supplement 2005; 26: 429.

  • Price DB, Williams AE, Yoxall S. Salmeterol/fluticasone stable-dose treatment compared with formoterol/budesonide adjustable maintenance dosing: impact on health-related quality of life. Respir Res. 2007 Jul 4;8(1):46. doi: 10.1186/1465-9921-8-46.

    PubMed 17610727

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Salmeterol/fluticasone propionate or formoterol/budesonide in people with Asthma, run by GlaxoSmithKline at 106 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in Canada, Netherlands, Germany, Spain, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean percentage of symptom-free days over a 52-week treatment period. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00479739, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.

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