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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293265
• Other study ID #: 201722
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2014
• Last updated: March 31, 2016
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Coffs Harbour	New South Wales
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Grimsby	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Québec	Quebec
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Sherwood Park	Alberta
Canada	GSK Investigational Site	St-Charles-Borromée	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivières	Quebec
Canada	GSK Investigational Site	Windsor	Ontario
France	GSK Investigational Site	Bayonne cedex
France	GSK Investigational Site	Dijon Cedex
France	GSK Investigational Site	Grenoble cedex 9
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Lyon cedex 04
France	GSK Investigational Site	Marseille cedex 03
France	GSK Investigational Site	Nantes cedex 1
France	GSK Investigational Site	Nantes cedex 2
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Pessac cedex
France	GSK Investigational Site	Reims Cedex
France	GSK Investigational Site	Rouen Cedex
France	GSK Investigational Site	Strasbourg
France	GSK Investigational Site	Tarbes cedex 9
France	GSK Investigational Site	Villefranche sur Saône
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Cottbus	Brandenburg
Germany	GSK Investigational Site	Gauting	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Schleswig	Schleswig-Holstein
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Cambridge
United Kingdom	GSK Investigational Site	Crawley
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Middlesbrough
United Kingdom	GSK Investigational Site	Radstock, Bath
United Kingdom	GSK Investigational Site	Salford
United Kingdom	GSK Investigational Site	Trowbridge
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	Corning	New York
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plymouth	Minnesota
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Rolling Hills Estates	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Shelby	North Carolina
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months		Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean and median levels of blood eosinophils		Day 1
Secondary	Mean and median levels of total IgE		Day 1
Secondary	Mean and median levels of specific IgE		Day 1
Secondary	Descriptive statistics for asthma Control Questionnaire (ACQ-5)		Day 1
Secondary	Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)		Day 1
Secondary	Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)		Day 1
Secondary	Descriptive statistics for EuroQol 5D (EQ-5D-5L)		Day 1
Secondary	Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)		Day 1
Secondary	Descriptive statistics for Asthma Symptom Utility Index (ASUI)		Day 1