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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00351143
First received: July 11, 2006
Last updated: November 10, 2011
Last verified: November 2011
History of Changes

July 11, 2006
November 10, 2011
July 2005
Not Provided
Total asthma control
Same as current
Complete list of historical versions of study NCT00351143 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Asthma
Behavioral: motivation asthma education (compliance enhancement)
Other Name: motivation asthma education (compliance enhancement)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Switzerland
 
NCT00351143
ACE104325
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP