A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
NCT ID: NCT00351143
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
274 participants
INTERVENTIONAL
2005-07-26
2007-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2
salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.
Control group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2
salmeterol/fluticasone propionate 50/250 µg
Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
Subjects receiving salmeterol/fluticasone propionate: Period 1
All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1
salmeterol/fluticasone propionate 50/250 µg
Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
Interventions
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salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.
salmeterol/fluticasone propionate 50/250 µg
Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
Eligibility Criteria
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Inclusion Criteria
* Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist).
* Female subjects must not be fertile or must use effective contraception.
* Subject must be able to comply with the use of the questionnaires in the local language.
Exclusion Criteria
* Pregnant or lactating.
* Participating investigator, employee of an investigator, or family member of any of the aforementioned.
* Smoking history: Pack-years \> 10 years.
* Have known clinical or laboratory evidence of a serious uncontrolled systemic disease.
* Known hypersensitivity to any substance contained in investigational product or as-needed medication.
* Treatment with oral corticosteroid within 2 months prior to the screening visit.
* Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit.
* Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Aalborg, , Denmark
GSK Investigational Site
Aarhus C, , Denmark
GSK Investigational Site
Hvidovre, , Denmark
GSK Investigational Site
København NV, , Denmark
GSK Investigational Site
Næstved, , Denmark
GSK Investigational Site
Odense C, , Denmark
GSK Investigational Site
Aarau, , Switzerland
GSK Investigational Site
Allschwil, , Switzerland
GSK Investigational Site
Basel, , Switzerland
GSK Investigational Site
Basel, , Switzerland
GSK Investigational Site
Basel, , Switzerland
GSK Investigational Site
Basel, , Switzerland
GSK Investigational Site
Basel, , Switzerland
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Bever, , Switzerland
GSK Investigational Site
Brittnau, , Switzerland
GSK Investigational Site
Castione, , Switzerland
GSK Investigational Site
Düdingen, , Switzerland
GSK Investigational Site
Egg, , Switzerland
GSK Investigational Site
Faltigberg-Wald, , Switzerland
GSK Investigational Site
Horw, , Switzerland
GSK Investigational Site
Klosters Platz, , Switzerland
GSK Investigational Site
Malvaglia, , Switzerland
GSK Investigational Site
Massagno, , Switzerland
GSK Investigational Site
Pregassona, , Switzerland
GSK Investigational Site
Steckborn, , Switzerland
GSK Investigational Site
Thun, , Switzerland
GSK Investigational Site
Wald, , Switzerland
GSK Investigational Site
Wigoltingen, , Switzerland
GSK Investigational Site
Worb, , Switzerland
Countries
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References
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Ulrik CS, Claudius BK, Tamm M, Harving H, Siersted HC, Backer V, Hellquist B, Dahl R, Hogholm A, Johnk IK. Effect of asthma compliance enhancement training on asthma control in patients on combination therapy with salmeterol/fluticasone propionate: a randomised controlled trial. Clin Respir J. 2009 Jul;3(3):161-8. doi: 10.1111/j.1752-699X.2009.00129.x.
Other Identifiers
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ACE104325
Identifier Type: -
Identifier Source: org_study_id
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