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

NCT ID: NCT02293265

Last Updated: 2016-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

767 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Short Acting Beta Agonist (SABA)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Little Rock, Arkansas, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Riverside, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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Upland, California, United States

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Tallahassee, Florida, United States

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Owensboro, Kentucky, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Minneapolis, Minnesota, United States

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Plymouth, Minnesota, United States

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Corning, New York, United States

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Charlotte, North Carolina, United States

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Shelby, North Carolina, United States

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Cincinnati, Ohio, United States

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Medford, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Coffs Harbour, New South Wales, Australia

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Sherwood Park, Alberta, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Grimsby, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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St-Charles-Borromée, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Bayonne, , France

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Dijon, , France

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Grenoble, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Nantes, , France

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Nantes, , France

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Paris, , France

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Pessac, , France

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Reims, , France

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Rouen, , France

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Strasbourg, , France

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Tarbes, , France

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Villefranche-sur-Saône, , France

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Gauting, Bavaria, Germany

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Munich, Bavaria, Germany

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Cottbus, Brandenburg, Germany

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Hamburg, City state of Hamburg, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Lübeck, Schleswig-Holstein, Germany

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Schleswig, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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GSK Investigational Site

Berlin, State of Berlin, Germany

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GSK Investigational Site

Berlin, State of Berlin, Germany

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GSK Investigational Site

Berlin, State of Berlin, Germany

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GSK Investigational Site

Birmingham, , United Kingdom

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GSK Investigational Site

Birmingham, , United Kingdom

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GSK Investigational Site

Cambridge, , United Kingdom

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GSK Investigational Site

Crawley, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Middlesbrough, , United Kingdom

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GSK Investigational Site

Radstock, Bath, , United Kingdom

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GSK Investigational Site

Salford, , United Kingdom

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GSK Investigational Site

Trowbridge, , United Kingdom

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Countries

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United States Australia Canada France Germany United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31874051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31251094 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28622052 (View on PubMed)

Other Identifiers

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201722

Identifier Type: -

Identifier Source: org_study_id

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