Clinical trial NCT02293265: Cross-sectional Study for Identification and Description of Severe Asthma Patients
Official title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: mepolizumab
omalizumab
SB-240563
Severe Asthma
reslizumab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 767
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of severe asthma patients eligible for one or more biologic treatments for asthma
timeFrame: Day 1
Secondary outcomes:
measure: Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
timeFrame: Day 1
measure: Mean and median Charlson Comorbidity Index score
timeFrame: Day 1
measure: Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
timeFrame: Day 1
measure: Mean post-bronchodilator FEV1/FVC ratio
timeFrame: Day 1
measure: Mean pre-bronchodilator FEV1
timeFrame: Day 1
measure: Mean post-bronchodilator FEV1
timeFrame: Day 1
measure: Mean pre-bronchodilator FVC
timeFrame: Day 1
measure: Mean post-bronchodilator FVC
timeFrame: Day 1
measure: Mean and median levels of blood eosinophils
timeFrame: Day 1
measure: Mean and median levels of total IgE
timeFrame: Day 1
measure: Mean and median levels of specific IgE
timeFrame: Day 1
measure: Descriptive statistics for asthma Control Questionnaire (ACQ-5)
timeFrame: Day 1
measure: Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Day 1
measure: Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)
timeFrame: Day 1
measure: Descriptive statistics for EuroQol 5D (EQ-5D-5L)
timeFrame: Day 1
measure: Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)
timeFrame: Day 1
measure: Descriptive statistics for Asthma Symptom Utility Index (ASUI)
timeFrame: Day 1
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Tallahassee
country: United States
facility: GSK Investigational Site
state: Florida
city: Owensboro
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Corning
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Coffs Harbour
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Sherwood Park
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Grimsby
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: St-Charles-Borromée
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivières
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Bayonne cedex
country: France
facility: GSK Investigational Site
city: Dijon Cedex
country: France
facility: GSK Investigational Site
city: Grenoble cedex 9
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: GSK Investigational Site
city: Lyon cedex 04
country: France
facility: GSK Investigational Site
city: Marseille cedex 03
country: France
facility: GSK Investigational Site
city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Nantes cedex 2
country: France
facility: GSK Investigational Site
city: Paris Cedex 18
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Reims Cedex
country: France
facility: GSK Investigational Site
city: Rouen Cedex
country: France
facility: GSK Investigational Site
city: Strasbourg
country: France
facility: GSK Investigational Site
city: Tarbes cedex 9
country: France
facility: GSK Investigational Site
city: Villefranche sur Saône
country: France
facility: GSK Investigational Site
city: Gauting
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Schleswig
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
city: Crawley
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Middlesbrough
country: United Kingdom
facility: GSK Investigational Site
city: Radstock, Bath
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
city: Trowbridge
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.