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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:
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
  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 Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training Drug: salmeterol/fluticasone propionate 50/250 µg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 274
Actual Study Start Date: July 26, 2005
Study Completion Date: June 13, 2007
Primary Completion Date: June 13, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Active Comparator: Control group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment 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: 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
Drug: salmeterol/fluticasone propionate 50/250 µg
Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 4031
GSK Investigational Site
Basel, Switzerland, 4053
GSK Investigational Site
Basel, Switzerland, 4054
GSK Investigational Site
Basel, Switzerland, 4058
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00351143     History of Changes
Other Study ID Numbers: ACE104325
First Submitted: July 11, 2006
First Posted: July 12, 2006
Last Update Posted: September 11, 2017
Last Verified: September 2017

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
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists