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

September 8, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • 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
        • GSK Investigational Site
  • Switzerland
      • Aarau, Switzerland, 5000
        • GSK Investigational Site
      • Allschwil, Switzerland, 4123
        • GSK Investigational Site
      • Basel, Switzerland, 4031
        • GSK Investigational Site
      • Basel, Switzerland, 4001
        • GSK Investigational Site
      • Basel, Switzerland, 4053
        • GSK Investigational Site
      • Basel, Switzerland, 4054
        • GSK Investigational Site
      • Basel, Switzerland, 4058
        • GSK Investigational Site
      • Bern, Switzerland, 3011
        • GSK Investigational Site
      • Bern, Switzerland, 3007
        • 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
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 12
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.
Up to Week 24
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.
Up to Week 24
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.
Up to Week 24
Asthma symptom score
Time Frame: Up to Week 24
Asthma symptom score will be analyzed to check the symptom severity
Up to Week 24
Number of subjects using rescue medication
Time Frame: Up to Week 24
Rescue medication usage will be analyzed.
Up to Week 24
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.
Up to Week 24
Asthma severity score
Time Frame: Up to Week 24
Asthma severity score will be analyzed
Up to Week 24
Number of subjects with adverse events (AEs)
Time Frame: Up to Week 24
Adverse events will be observed and counted.
Up to Week 24
AQLQ score
Time Frame: Up to Week 24
Quality of life of subjects with asthma will be analyzed.
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2005

Primary Completion (Actual)

June 13, 2007

Study Completion (Actual)

June 13, 2007

Study Registration Dates

First Submitted

July 11, 2006

First Submitted That Met QC Criteria

July 11, 2006

First Posted (Estimate)

July 12, 2006

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE104325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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