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Completed

NCT Number: NCT02293265

Cross-sectional Study for Identification and Description of Severe Asthma Patients

This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Coffs Harbour, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 12 years of age at study visit.
  • Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months).

Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).

SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.

  • Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. A parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws).

Exclusion criteria

Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)

Treatment and study plan

Short Acting Beta Agonist (SABA)

Drug

Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments

Primary outcomes

  1. Number of severe asthma patients eligible for one or more biologic treatments for asthma

    Time frame: Day 1

    Biologic treatments for asthma will include mepolizumab (anti-Interleukin [IL] 5), omalizumab (anti-immunoglobulin E [IgE]), and reslizumab (anti-IL5).

Secondary outcomes

  1. Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months

    Time frame: Day 1

  2. Mean and median Charlson Comorbidity Index score

    Time frame: Day 1

    The Charlson Comorbidity Index is a score that is based on age and the presence of 19 comorbidities. The mean and median Charlson Comorbidity Index score will be calculated and reported

  3. Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio

    Time frame: Day 1

    Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility

  4. Mean post-bronchodilator FEV1/FVC ratio

    Time frame: Day 1

    Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility

  5. Mean pre-bronchodilator FEV1

    Time frame: Day 1

    Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility

  6. Mean post-bronchodilator FEV1

    Time frame: Day 1

    Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility

  7. Mean pre-bronchodilator FVC

    Time frame: Day 1

    Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility

  8. Mean post-bronchodilator FVC

    Time frame: Day 1

    Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility

  9. Mean and median levels of blood eosinophils

    Time frame: Day 1

  10. Mean and median levels of total IgE

    Time frame: Day 1

  11. Mean and median levels of specific IgE

    Time frame: Day 1

  12. Descriptive statistics for asthma Control Questionnaire (ACQ-5)

    Time frame: Day 1

  13. Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)

    Time frame: Day 1

  14. Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)

    Time frame: Day 1

  15. Descriptive statistics for EuroQol 5D (EQ-5D-5L)

    Time frame: Day 1

  16. Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)

    Time frame: Day 1

  17. Descriptive statistics for Asthma Symptom Utility Index (ASUI)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2014
Registry last updated
Apr 4, 2016

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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