RecruitingPhase 3interventionalRules rewrite

Phase 3: testing HFA-152a for Asthma

This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).

Official registry: https://clinicaltrials.gov/study/NCT07645248 · GlaxoSmithKline · enrollment listed as 110

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HFA-152a, or HFA-134a. The registry lists allocation as randomized. This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).

They plan to enroll about 110 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Double-blind, 2-way Crossover, Multicenter Study to Evaluate the Safety of Test Propellant HFA-152a and Reference Propellant HFA-134a When Administered Via Metered Dose Inhalers

Interventions: HFA-152a, HFA-134a

Primary outcome (registry wording): Number of participants with adverse events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Participants with asthma for \>= 6 months, defined as:
Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
Receiving one of following asthma treatments for at least 12 weeks prior to the screening visit and which is anticipated to remain stable for the duration of the study:
Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
Inhaled corticosteroid (ICS)/SABA prn only
SABA prn plus ICS prn
SABA prn plus ICS maintenance

Who the registry excludes

Participants with a history of life-threatening asthma
Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening
Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis)
Participants with any other prescription or over the counter medication which would significantly affect the course of asthma, or that could interact with sympathomimetic amines
Participants with Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.)
Participants with exposure to more than four new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer
Participants with a known or suspected history of alcohol or drug abuse

Public study contact (from the registry)

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

18 listed

GSK Investigational Site — Aventura, Florida (recruiting)
GSK Investigational Site — Miami, Florida (recruiting)
GSK Investigational Site — Naples, Florida (recruiting)
GSK Investigational Site — Owensboro, Kentucky (recruiting)
GSK Investigational Site — Columbia, Missouri (recruiting)
GSK Investigational Site — Henderson, Nevada (recruiting)
GSK Investigational Site — Medford, Oregon (recruiting)
GSK Investigational Site — Spartanburg, South Carolina (recruiting)
GSK Investigational Site — Cypress, Texas (recruiting)
GSK Investigational Site — Tomball, Texas (recruiting)

+ 8 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07645248 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07645248?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07645248?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary