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AsthmaPhase 3NCT02293265

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

A Phase 3 study testing Short Acting Beta Agonist (SABA) in people with Asthma, run by GlaxoSmithKline at 74 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Short Acting Beta Agonist (SABA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
767 participants
Where
74 sitesin 6 countries
Study dates
Dec 2014to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

74 sites in 6 countries.

74 sites in 6 countries

United States21 sites

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Corning, New York, 14830

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    Shelby, North Carolina, 28150

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Upland, California, 91786

Other trials in United States

France15 sites

  • GSK Investigational Site

    Bayonne, 64109

  • GSK Investigational Site

    Dijon, 21033

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Lyon, 69317

  • GSK Investigational Site

    Marseille, 13331

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nantes, 44277

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Reims, 51092

  • GSK Investigational Site

    Rouen, 76031

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Tarbes, 65013

  • GSK Investigational Site

    Villefranche-sur-Saône, 69655

Other trials in France

Canada14 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Grimsby, Ontario, L3M1P3

  • GSK Investigational Site

    London, Ontario, N6A1V2

  • GSK Investigational Site

    Mississauga, Ontario, L5A 3V4

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G1V 4M6

  • GSK Investigational Site

    Sherwood Park, Alberta, T8H 0N2

  • GSK Investigational Site

    St-Charles-Borromée, Ontario, J6E 2B4

  • GSK Investigational Site

    Toronto, Ontario, M5G 1E2

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Windsor, Ontario, N8X2G1

Other trials in Canada

Germany13 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 10717

  • GSK Investigational Site

    Berlin, State of Berlin, 12157

  • GSK Investigational Site

    Berlin, State of Berlin, 12203

  • GSK Investigational Site

    Berlin, State of Berlin, 13086

  • GSK Investigational Site

    Berlin, State of Berlin, 13597

  • GSK Investigational Site

    Cottbus, Brandenburg, 03050

  • GSK Investigational Site

    Gauting, Bavaria, 82131

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22299

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Munich, Bavaria, 80539

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein, 24837

Other trials in Germany

United Kingdom10 sites

  • GSK Investigational Site

    Birmingham, B15 2WB

  • GSK Investigational Site

    Birmingham, B18 7QH

  • GSK Investigational Site

    Cambridge, CB2 2XY

  • GSK Investigational Site

    Crawley, RH10 7DX

  • GSK Investigational Site

    Liverpool, L12 2AP

  • GSK Investigational Site

    London, SW17 0RE

  • GSK Investigational Site

    Middlesbrough, TS4 3BW

  • GSK Investigational Site

    Radstock, Bath, BA3 2UH

  • GSK Investigational Site

    Salford, M6 8HD

  • GSK Investigational Site

    Trowbridge, BA14 9AR

Other trials in United Kingdom

Australia1 site

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

Other trials in Australia

About this study

Official title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study

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.

Conditions
Asthma
Being tested
Short Acting Beta Agonist (SABA)
Keywords
mepolizumab, omalizumab, SB-240563, Severe Asthma, reslizumab
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short Acting Beta Agonist (SABA)Drug

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

Study groups in NCT02293265
Study groupRoleWhat they receive
Non-drug interventional groupOtherAll 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.
Receives: Drug: Short Acting Beta Agonist (SABA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 1

Secondary outcomes (17)

  1. Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months

    Measured: Day 1

  2. 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

    Measured: Day 1

  3. 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

    Measured: Day 1

  4. 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

    Measured: Day 1

  5. 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

    Measured: Day 1

  6. 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

    Measured: Day 1

  7. 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

    Measured: Day 1

  8. 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

    Measured: Day 1

  9. Mean and median levels of blood eosinophils

    Measured: Day 1

  10. Mean and median levels of total IgE

    Measured: Day 1

  11. Mean and median levels of specific IgE

    Measured: Day 1

  12. Descriptive statistics for asthma Control Questionnaire (ACQ-5)

    Measured: Day 1

  13. Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)

    Measured: Day 1

  14. Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)

    Measured: Day 1

  15. Descriptive statistics for EuroQol 5D (EQ-5D-5L)

    Measured: Day 1

  16. Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)

    Measured: Day 1

  17. Descriptive statistics for Asthma Symptom Utility Index (ASUI)

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
767 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293265
Sponsor's protocol ID
201722
Status last verified
Mar 2016
First submitted
27 Oct 2014
Last updated
4 Apr 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 31874051

  • 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.

    PubMed 31251094

  • 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.

    PubMed 28622052

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Short Acting Beta Agonist (SABA) in people with Asthma, run by GlaxoSmithKline at 74 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, France, Canada, Germany, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of severe asthma patients eligible for one or more biologic treatments for asthma (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293265, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.

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