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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Short Acting Beta Agonist (SABA)

• Study Type: Interventional
• Enrollment (Actual): 767
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
• Canada
  • Alberta
    • Sherwood Park, Alberta, Canada, T8H 0N2
      • GSK Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • GSK Investigational Site
    • Burlington, Ontario, Canada, L7N 3V2
      • GSK Investigational Site
    • Grimsby, Ontario, Canada, L3M1P3
      • GSK Investigational Site
    • London, Ontario, Canada, N6A1V2
      • GSK Investigational Site
    • Mississauga, Ontario, Canada, L5A 3V4
      • GSK Investigational Site
    • St-Charles-Borromée, Ontario, Canada, J6E 2B4
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 1E2
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5T 3A9
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X2G1
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
    • Quebec City, Quebec, Canada, G1V 4M6
      • GSK Investigational Site
    • Québec, Quebec, Canada, G1V 4G5
      • GSK Investigational Site
    • Trois Rivières, Quebec, Canada, G8T 7A1
      • GSK Investigational Site
• France
  • Bayonne cedex, France, 64109
    • GSK Investigational Site
  • Dijon Cedex, France, 21033
    • GSK Investigational Site
  • Grenoble cedex 9, France, 38043
    • GSK Investigational Site
  • Lille Cedex, France, 59037
    • GSK Investigational Site
  • Lyon cedex 04, France, 69317
    • GSK Investigational Site
  • Marseille cedex 03, France, 13331
    • GSK Investigational Site
  • Nantes cedex 1, France, 44093
    • GSK Investigational Site
  • Nantes cedex 2, France, 44277
    • GSK Investigational Site
  • Paris Cedex 18, France, 75877
    • GSK Investigational Site
  • Pessac cedex, France, 33604
    • GSK Investigational Site
  • Reims Cedex, France, 51092
    • GSK Investigational Site
  • Rouen Cedex, France, 76031
    • GSK Investigational Site
  • Strasbourg, France, 67091
    • GSK Investigational Site
  • Tarbes cedex 9, France, 65013
    • GSK Investigational Site
  • Villefranche sur Saône, France, 69655
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13086
    • GSK Investigational Site
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 13597
    • GSK Investigational Site
  • Berlin, Germany, 12203
    • GSK Investigational Site
  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Hamburg, Germany, 22299
    • GSK Investigational Site
  • Bayern
    • Gauting, Bayern, Germany, 82131
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80539
      • GSK Investigational Site
  • Brandenburg
    • Cottbus, Brandenburg, Germany, 03050
      • GSK Investigational Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04357
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23552
      • GSK Investigational Site
    • Schleswig, Schleswig-Holstein, Germany, 24837
      • GSK Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • GSK Investigational Site
  • Birmingham, United Kingdom, B18 7QH
    • GSK Investigational Site
  • Cambridge, United Kingdom, CB2 2XY
    • GSK Investigational Site
  • Crawley, United Kingdom, RH10 7DX
    • GSK Investigational Site
  • Liverpool, United Kingdom, L12 2AP
    • GSK Investigational Site
  • London, United Kingdom, SW17 0RE
    • GSK Investigational Site
  • Middlesbrough, United Kingdom, TS4 3BW
    • GSK Investigational Site
  • Radstock, Bath, United Kingdom, BA3 2UH
    • GSK Investigational Site
  • Salford, United Kingdom, M6 8HD
    • GSK Investigational Site
  • Trowbridge, United Kingdom, BA14 9AR
    • GSK Investigational Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Los Angeles, California, United States, 90025
      • GSK Investigational Site
    • Newport Beach, California, United States, 92663
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • Rolling Hills Estates, California, United States, 90274
      • GSK Investigational Site
    • San Diego, California, United States, 92123
      • GSK Investigational Site
    • Upland, California, United States, 91786
      • GSK Investigational Site
  • Florida
    • Tallahassee, Florida, United States, 32308
      • GSK Investigational Site
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • GSK Investigational Site
    • Columbia, Maryland, United States, 21044
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • GSK Investigational Site
    • Plymouth, Minnesota, United States, 55441
      • GSK Investigational Site
  • New York
    • Corning, New York, United States, 14830
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • GSK Investigational Site
    • Shelby, North Carolina, United States, 28150
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Non-drug interventional group; All enrolled participants will provide a blood sample, spirometry , and feedback on their severe asthma symptoms via questionnaires, and health related quality of life and burden of illness through response to self-administered questionnaires. No investigational product will be administered to participants.	Drug: Short Acting Beta Agonist (SABA); Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of severe asthma patients eligible for one or more biologic treatments for asthma	Biologic treatments for asthma will include mepolizumab (anti-Interleukin [IL] 5), omalizumab (anti-immunoglobulin E [IgE]), and reslizumab (anti-IL5).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months		Day 1
Mean and median Charlson Comorbidity Index score	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	Day 1
Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio	Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility	Day 1
Mean post-bronchodilator FEV1/FVC ratio	Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility	Day 1
Mean pre-bronchodilator FEV1	Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility	Day 1
Mean post-bronchodilator FEV1	Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility	Day 1
Mean pre-bronchodilator FVC	Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility	Day 1
Mean post-bronchodilator FVC	Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility	Day 1
Mean and median levels of blood eosinophils		Day 1
Mean and median levels of total IgE		Day 1
Mean and median levels of specific IgE		Day 1
Descriptive statistics for asthma Control Questionnaire (ACQ-5)		Day 1
Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)		Day 1
Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)		Day 1
Descriptive statistics for EuroQol 5D (EQ-5D-5L)		Day 1
Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)		Day 1
Descriptive statistics for Asthma Symptom Utility Index (ASUI)		Day 1

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.
• Mullerova H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2021 Apr;58(4):459-470. doi: 10.1080/02770903.2019.1708095. Epub 2020 Jan 9.
• Albers FC, Mullerova H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018 Feb;55(2):152-160. doi: 10.1080/02770903.2017.1322611. Epub 2017 Jun 16.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: mepolizumab; Severe Asthma; omalizumab; SB-240563; reslizumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 201722