We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00351143
First Posted: July 12, 2006
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
July 11, 2006
July 12, 2006
September 11, 2017
July 26, 2005
June 13, 2007   (Final data collection date for primary outcome measure)
number of subjects who achieved Total asthma Control: Period 2 [ Time Frame: Up to Week 24 ]
Proportion of subjects who achieved Total Control in 7 out of the last 8 consecutive weeks in treatment period 2 with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing and compliance enhancement training compared with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing without compliance enhancement training.
Total asthma control
Complete list of historical versions of study NCT00351143 on ClinicalTrials.gov Archive Site
  • Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2 [ Time Frame: Up to Week 12 ]
    Proportion of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing in treatment period 1 will be analyzed.
  • Time to first individual week with Total Control [ Time Frame: Up to Week 24 ]
    Time to first individual week with Total Control in treatment period 2 will be analyzed.
  • Morning peak expiratory flow (PEF) [ Time Frame: Up to Week 24 ]
    PEF is defined as a person's maximum speed of expiration and will be measured using a peak flow meter.
  • Forced expiratory volume in one second (FEV1) [ Time Frame: Up to Week 24 ]
    FEV1 is defined as Forced Expiratory Volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function.
  • Asthma symptom score [ Time Frame: Up to Week 24 ]
    Asthma symptom score will be analyzed to check the symptom severity
  • Number of subjects using rescue medication [ Time Frame: Up to Week 24 ]
    Rescue medication usage will be analyzed.
  • Number of nights with awakening due to asthma [ Time Frame: Up to Week 24 ]
    Number of nights with awakening due to asthma will be analyzed.
  • Asthma severity score [ Time Frame: Up to Week 24 ]
    Asthma severity score will be analyzed
  • Number of subjects with adverse events (AEs) [ Time Frame: Up to Week 24 ]
    Adverse events will be observed and counted.
  • AQLQ score [ Time Frame: Up to Week 24 ]
    Quality of life of subjects with asthma will be analyzed.
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
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
  • Drug: 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.
  • Drug: salmeterol/fluticasone propionate 50/250 µg
    Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2
  • Experimental: Interventional group: Period 2
    Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2
    Intervention: Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
  • Active Comparator: Control group: Period 2
    Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2
    Intervention: Drug: salmeterol/fluticasone propionate 50/250 µg
  • Experimental: 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
    Intervention: Drug: salmeterol/fluticasone propionate 50/250 µg
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. doi: 10.1111/j.1752-699X.2009.00129.x. Erratum in: Clin Respir J. 2009 Jul;3(3):185.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
June 13, 2007
June 13, 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Switzerland
 
 
NCT00351143
ACE104325
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2017

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