Inhaler Propellants for Asthma

Recruiting at 1 trial location

Overseen By US GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must be taking: SABA, ICS, LTRAs

Must not be taking: Biologics, Systemic corticosteroids

Disqualifiers: Life-threatening asthma, Respiratory disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the propellants,1 - Difluoroethane \[HFA-152a\] (Test) and 1,1,1,2-Tetrafluoroethane \[HFA-134a\] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.

Eligibility Criteria

This trial is for adults aged 18-45 with mild asthma, diagnosed at least 6 months ago. They must have stable asthma without severe flare-ups in the past 6 months and not be on certain medications or therapies. Women of childbearing age should meet pregnancy prevention criteria.

Inclusion Criteria

ACQ-6 score <1.5 at screening and Day -1

I am either a man or a woman, regardless of my ability to have children.

I am not pregnant and follow the required birth control measures.

Exclusion Criteria

I have had severe or uncontrolled asthma.

I am currently undergoing de-sensitization therapy.

My medication doses have not changed recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single doses of HFA-152a and HFA-134a propellants via pressurized metered dose inhalers in a cross-over design

1-2 weeks

Follow-up

Participants are monitored for airway sensitivity reactions after treatment

4 weeks

Treatment Details

Interventions

• HFA-134A propellant
• HFA-152A propellant

Trial Overview The study compares two propellants used in inhalers: HFA-152a (test) and HFA-134a (reference). It aims to see if they cause airway tightening when used by people with mild asthma, looking for a greener option with less impact on global warming.

Participant Groups

Group I: HFA-152A propellant followed by HFA-134A propellant Experimental Treatment 2 Interventions

Group II: HFA-134A propellant followed by HFA-152A propellant Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School