A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00351143

Purpose

This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.

Condition	Intervention	Phase
Asthma	Behavioral: motivation asthma education (compliance enhancement)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	A Randomized, Open Label Comparative Study to Determine the Proportion of Asthma Patients on SERETIDE Diskus 50/250 Mcg b.i.d. Achieving Total Control When Given Medication and Compliance Enhancement Training Compared to Those Receiving Medication Only.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Total asthma control

Secondary Outcome Measures:

Morning Peak Expiratory Flow, Day symptom score, Rescue medication use, Number of nights on which awakening occurred because of asthma, Adverse Events, Quality of Life questionnaire, Medication compliance, Asthma severity

Estimated Enrollment:	550
Study Start Date:	July 2005

Intervention Details:

Other Name: motivation asthma education (compliance enhancement)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosed with persistent asthma.
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:

Known or suspected Chronic Obstructive Pulmonary Disease.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351143

Locations

Denmark
GSK Investigational Site
Aalborg, Denmark, DK-9100
GSK Investigational Site
Aarhus C, Denmark, DK-8000
GSK Investigational Site
Hvidovre, Denmark, 2650
GSK Investigational Site
Kobenhavn NV, Denmark, 2400
GSK Investigational Site
Naestved, Denmark, 4700
GSK Investigational Site
Odense C, Denmark, 5000
Switzerland
GSK Investigational Site
Aarau, Switzerland, 5000
GSK Investigational Site
Allschwil, Switzerland, 4123
GSK Investigational Site
Basel, Switzerland, 4001
GSK Investigational Site
Basel, Switzerland, 4058
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Basel, Switzerland, 4053
GSK Investigational Site
Basel, Switzerland, 4054
GSK Investigational Site
Bern, Switzerland, 3007
GSK Investigational Site
Bern, Switzerland, 3011
GSK Investigational Site
Bern, Switzerland, 3012
GSK Investigational Site
Bever, Switzerland, 7502
GSK Investigational Site
Brittnau, Switzerland, 4805
GSK Investigational Site
Castione, Switzerland, 6532
GSK Investigational Site
Düdingen, Switzerland, 3186
GSK Investigational Site
Egg, Switzerland, 8132
GSK Investigational Site
Faltigberg-Wald, Switzerland, 8639
GSK Investigational Site
Horw, Switzerland, 6048
GSK Investigational Site
Klosters, Switzerland, 7250
GSK Investigational Site
Malvaglia, Switzerland, 6713
GSK Investigational Site
Massagno, Switzerland, 6900
GSK Investigational Site
Pregassona, Switzerland, 6963
GSK Investigational Site
Steckborn, Switzerland, 8266
GSK Investigational Site
Thun, Switzerland, 3600
GSK Investigational Site
Wald, Switzerland, 8636
GSK Investigational Site
Wigoltingen, Switzerland, 8556
GSK Investigational Site
Worb, Switzerland, 3076

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ulrik CS, Claudius BK, Tamm M, Harving H, Siersted HC, Backer V, Hellquist B, Dahl R, Høgholm A, Jøhnk 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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00351143 History of Changes
Other Study ID Numbers:	ACE104325
Study First Received:	July 11, 2006
Last Updated:	November 10, 2011
Health Authority:	Denmark: Ethics Committee

Keywords provided by GlaxoSmithKline:

QoL
Asthma
asthma compliance enhancement
Salmeterol/fluticasone

Total control
SERETIDE
FEV1

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012