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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study
Secondary ID [1] 0 0
201722
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of severe asthma patients eligible for one or more biologic treatments for asthma
Timepoint [1] 0 0
Day 1
Secondary outcome [1] 0 0
Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Mean and median Charlson Comorbidity Index score
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Mean post-bronchodilator FEV1/FVC ratio
Timepoint [4] 0 0
Day 1
Secondary outcome [5] 0 0
Mean pre-bronchodilator FEV1
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
Mean post-bronchodilator FEV1
Timepoint [6] 0 0
Day 1
Secondary outcome [7] 0 0
Mean pre-bronchodilator FVC
Timepoint [7] 0 0
Day 1
Secondary outcome [8] 0 0
Mean post-bronchodilator FVC
Timepoint [8] 0 0
Day 1
Secondary outcome [9] 0 0
Mean and median levels of blood eosinophils
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Mean and median levels of total IgE
Timepoint [10] 0 0
Day 1
Secondary outcome [11] 0 0
Mean and median levels of specific IgE
Timepoint [11] 0 0
Day 1
Secondary outcome [12] 0 0
Descriptive statistics for asthma Control Questionnaire (ACQ-5)
Timepoint [12] 0 0
Day 1
Secondary outcome [13] 0 0
Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)
Timepoint [13] 0 0
Day 1
Secondary outcome [14] 0 0
Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)
Timepoint [14] 0 0
Day 1
Secondary outcome [15] 0 0
Descriptive statistics for EuroQol 5D (EQ-5D-5L)
Timepoint [15] 0 0
Day 1
Secondary outcome [16] 0 0
Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)
Timepoint [16] 0 0
Day 1
Secondary outcome [17] 0 0
Descriptive statistics for Asthma Symptom Utility Index (ASUI)
Timepoint [17] 0 0
Day 1

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).
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
767
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
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Minnesota
Country [7] 0 0
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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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
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
Country [22] 0 0
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
State/province [29] 0 0
Tarbes cedex 9
Country [30] 0 0
France
State/province [30] 0 0
Villefranche sur Saône
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
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
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Salford
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Trowbridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02293265
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02293265