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

NCT02293265 | Completed Phase 3

• 1 other identifier: 201722
• Study Type: interventional
• Target: 767
• Locations: 6 countries
• Sites: 74

Brief Summary

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.

Conditions

Asthma

Keywords

mepolizumab; omalizumab; SB-240563; Severe Asthma; reslizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

  Day 1

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

  Day 1

• Mean post-bronchodilator FEV1/FVC ratio

  Day 1

• Mean pre-bronchodilator FEV1

  Day 1

Study Arms (1)

Non-drug interventional group

OTHER

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)

Interventions

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

Non-drug interventional group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (74)

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Fresno, California, 93720, United States

Location

GSK Investigational Site

Los Angeles, California, 90025, United States

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GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

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GSK Investigational Site

San Diego, California, 92123, United States

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GSK Investigational Site

Upland, California, 91786, United States

Location

GSK Investigational Site

Tallahassee, Florida, 32308, United States

Location

GSK Investigational Site

Owensboro, Kentucky, 42301, United States

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GSK Investigational Site

Baltimore, Maryland, 21236, United States

Location

GSK Investigational Site

Columbia, Maryland, 21044, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

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GSK Investigational Site

Plymouth, Minnesota, 55441, United States

Location

GSK Investigational Site

Corning, New York, 14830, United States

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GSK Investigational Site

Charlotte, North Carolina, 28277, United States

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GSK Investigational Site

Shelby, North Carolina, 28150, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

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GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

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GSK Investigational Site

Greenville, South Carolina, 29615, United States

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GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

Location

GSK Investigational Site

Sherwood Park, Alberta, T8H 0N2, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

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GSK Investigational Site

Burlington, Ontario, L7N 3V2, Canada

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GSK Investigational Site

Grimsby, Ontario, L3M1P3, Canada

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GSK Investigational Site

London, Ontario, N6A1V2, Canada

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GSK Investigational Site

Mississauga, Ontario, L5A 3V4, Canada

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GSK Investigational Site

St-Charles-Borromée, Ontario, J6E 2B4, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1E2, Canada

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GSK Investigational Site

Toronto, Ontario, M5T 3A9, Canada

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GSK Investigational Site

Windsor, Ontario, N8X2G1, Canada

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GSK Investigational Site

Montreal, Quebec, H4J 1C5, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4G5, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4M6, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Bayonne, 64109, France

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GSK Investigational Site

Dijon, 21033, France

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GSK Investigational Site

Grenoble, 38043, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Lyon, 69317, France

Location

GSK Investigational Site

Marseille, 13331, France

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GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Nantes, 44277, France

Location

GSK Investigational Site

Paris, 75877, France

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GSK Investigational Site

Pessac, 33604, France

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GSK Investigational Site

Reims, 51092, France

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GSK Investigational Site

Rouen, 76031, France

Location

GSK Investigational Site

Strasbourg, 67091, France

Location

GSK Investigational Site

Tarbes, 65013, France

Location

GSK Investigational Site

Villefranche-sur-Saône, 69655, France

Location

GSK Investigational Site

Gauting, Bavaria, 82131, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80539, Germany

Location

GSK Investigational Site

Cottbus, Brandenburg, 03050, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 22299, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04357, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

Location

GSK Investigational Site

Schleswig, Schleswig-Holstein, 24837, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12157, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12203, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13086, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13597, Germany

Location

GSK Investigational Site

Birmingham, B15 2WB, United Kingdom

Location

GSK Investigational Site

Birmingham, B18 7QH, United Kingdom

Location

GSK Investigational Site

Cambridge, CB2 2XY, United Kingdom

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GSK Investigational Site

Crawley, RH10 7DX, United Kingdom

Location

GSK Investigational Site

Liverpool, L12 2AP, United Kingdom

Location

GSK Investigational Site

London, SW17 0RE, United Kingdom

Location

GSK Investigational Site

Middlesbrough, TS4 3BW, United Kingdom

Location

GSK Investigational Site

Radstock, Bath, BA3 2UH, United Kingdom

Location

GSK Investigational Site

Salford, M6 8HD, United Kingdom

Location

GSK Investigational Site

Trowbridge, BA14 9AR, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 31874051 DERIVED

• 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.

  PMID: 31251094 DERIVED

• 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.

  PMID: 28622052 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 18, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

FR (15); DE (13); CA (14); GB (10); US (21); AU (1)