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

Sponsored by:	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

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Efficacy Study
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.

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

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

Show 47 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ACE104325
Study First Received:	July 11, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00351143
Health Authority:	Denmark: Ethics Committee

Keywords provided by GlaxoSmithKline:

Asthma
Total control
asthma compliance enhancement
FEV1

QoL
SERETIDE
Salmeterol/fluticasone

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009