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Completed

NCT Number: NCT00351143

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training

Drug

Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.

salmeterol/fluticasone propionate 50/250 µg

Drug

Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Asthma symptom score

    Time frame: Up to Week 24

    Asthma symptom score will be analyzed to check the symptom severity

  6. Number of subjects using rescue medication

    Time frame: Up to Week 24

    Rescue medication usage will be analyzed.

  7. 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.

  8. Asthma severity score

    Time frame: Up to Week 24

    Asthma severity score will be analyzed

  9. Number of subjects with adverse events (AEs)

    Time frame: Up to Week 24

    Adverse events will be observed and counted.

  10. AQLQ score

    Time frame: Up to Week 24

    Quality of life of subjects with asthma will be analyzed.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 12, 2006
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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