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Short Acting Beta Agonist

Phase 3

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Apr 4, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment767

FDA Designations

No designations recorded

Clinical trial landscape

Short Acting Beta Agonist · 1 trial · 1 indication

Phase 3 1
NCT02293265Cross-sectional Study for Identification and Description of Severe Asthma PatientsAsthma
COMPLETED767 Analytics
PHASE3COMPLETED
Cross-sectional Study for Identification and Description of Severe Asthma Patients
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of severe asthma patients eligible for one or more biologic treatments for asthma
Day 1

Biologic treatments for asthma will include mepolizumab (anti-Interleukin \[IL\] 5), omalizumab (anti-immunoglobulin E \[IgE\]), and reslizumab (anti-IL5).

Secondary Endpoints

Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
Day 1
Mean and median Charlson Comorbidity Index score
Day 1
Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
Day 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
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.

Interventions

NameTypeDescription
Short Acting Beta Agonist (SABA)DRUGParticipants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites74

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 Socie...

Countries:United StatesAustraliaCanadaFranceGermanyUnited Kingdom
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Frequently asked questions about Short Acting Beta Agonist

What is Short Acting Beta Agonist used for in asthma?

Short Acting Beta Agonist is a small molecule being developed for the treatment of asthma. It is currently in Phase 3 clinical development as an investigational therapy. The drug is intended to address respiratory conditions, specifically asthma, and is being studied in patients aged 12 years and older.

Who makes Short Acting Beta Agonist?

Short Acting Beta Agonist is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.

What phase is Short Acting Beta Agonist in?

Short Acting Beta Agonist is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for the treatment of asthma.

What clinical trials is Short Acting Beta Agonist in?

Short Acting Beta Agonist has one completed clinical trial registered under NCT02293265, titled "Cross-sectional Study for Identification and Description of Severe Asthma Patients." This Phase 3 study enrolled 767 participants with asthma across the United States, Australia, Canada, France, Germany, and the United Kingdom.

Is Short Acting Beta Agonist FDA approved?

Short Acting Beta Agonist is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for asthma. The completed clinical trial, NCT02293265, was an uncontrolled, non-randomized study that evaluated patients with severe asthma, but regulatory approval has not been granted.