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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02293265
Registration number
NCT02293265
Ethics application status
Date submitted
27/10/2014
Date registered
18/11/2014
Date last updated
4/04/2016
Titles & IDs
Public title
Cross-sectional Study for Identification and Description of Severe Asthma Patients
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Scientific title
Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study
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Secondary ID [1]
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201722
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Short Acting Beta Agonist (SABA)
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.
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of severe asthma patients eligible for one or more biologic treatments for asthma
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Assessment method [1]
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Biologic treatments for asthma will include mepolizumab (anti-Interleukin \[IL\] 5), omalizumab (anti-immunoglobulin E \[IgE\]), and reslizumab (anti-IL5).
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Timepoint [1]
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Day 1
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Secondary outcome [1]
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Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
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Assessment method [1]
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Timepoint [1]
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Day 1
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Secondary outcome [2]
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Mean and median Charlson Comorbidity Index score
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Assessment method [2]
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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
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Timepoint [2]
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Day 1
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Secondary outcome [3]
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Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
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Assessment method [3]
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Timepoint [3]
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Day 1
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Secondary outcome [4]
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Mean post-bronchodilator FEV1/FVC ratio
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Assessment method [4]
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Timepoint [4]
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Day 1
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Secondary outcome [5]
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Mean pre-bronchodilator FEV1
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Assessment method [5]
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Timepoint [5]
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Day 1
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Secondary outcome [6]
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Mean post-bronchodilator FEV1
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Assessment method [6]
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Timepoint [6]
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Day 1
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Secondary outcome [7]
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Mean pre-bronchodilator FVC
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Assessment method [7]
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Timepoint [7]
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Day 1
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Secondary outcome [8]
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Mean post-bronchodilator FVC
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Assessment method [8]
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Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
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Timepoint [8]
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Day 1
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Secondary outcome [9]
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Mean and median levels of blood eosinophils
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Assessment method [9]
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Timepoint [9]
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Day 1
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Secondary outcome [10]
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Mean and median levels of total IgE
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Assessment method [10]
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Timepoint [10]
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Day 1
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Secondary outcome [11]
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Mean and median levels of specific IgE
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Assessment method [11]
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Timepoint [11]
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Day 1
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Secondary outcome [12]
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Descriptive statistics for asthma Control Questionnaire (ACQ-5)
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Assessment method [12]
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Timepoint [12]
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Day 1
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Secondary outcome [13]
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Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)
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Assessment method [13]
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Timepoint [13]
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Day 1
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Secondary outcome [14]
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Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)
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Assessment method [14]
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Timepoint [14]
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Day 1
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Secondary outcome [15]
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Descriptive statistics for EuroQol 5D (EQ-5D-5L)
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Assessment method [15]
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Timepoint [15]
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Day 1
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Secondary outcome [16]
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Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)
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Assessment method [16]
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Timepoint [16]
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Day 1
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Secondary outcome [17]
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Descriptive statistics for Asthma Symptom Utility Index (ASUI)
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Assessment method [17]
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Timepoint [17]
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Day 1
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Eligibility
Key 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).
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/05/2015
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Sample size
Target
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Accrual to date
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Final
767
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Coffs Harbour
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment outside Australia
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oregon
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Pennsylvania
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United States of America
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South Carolina
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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France
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Bayonne cedex
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France
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Dijon Cedex
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France
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Grenoble cedex 9
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France
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Lille Cedex
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France
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Lyon cedex 04
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France
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Marseille cedex 03
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France
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Nantes cedex 1
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France
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Nantes cedex 2
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France
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Paris Cedex 18
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France
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Pessac cedex
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France
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Reims Cedex
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France
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Rouen Cedex
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France
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Strasbourg
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France
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Tarbes cedex 9
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France
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Villefranche sur Saône
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Crawley
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Middlesbrough
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United Kingdom
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Radstock, Bath
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United Kingdom
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Salford
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United Kingdom
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Trowbridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02293265
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Trial related presentations / publications
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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02293265
Download to PDF