Inhaler Propellants for Asthma

No longer recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two inhaler propellants, HFA-134A and HFA-152A, to determine if they cause airway tightening in people with asthma. The goal is to identify a more environmentally friendly option that reduces global warming impact. The trial seeks participants who have had asthma for at least six months and manage it with inhalers or other asthma treatments. Participants should not have experienced severe asthma attacks recently and must not smoke or use marijuana. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking environmental health research.

Will I have to stop taking my current medications?

You can continue taking your current asthma medications if they are stable and fall within the allowed treatments, like short-acting beta-agonists, low-dose inhaled corticosteroids, or leukotriene receptor antagonists. However, if you are on biologic agents or certain other treatments, you may not be eligible for the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HFA-134a, a common ingredient in inhalers, is generally safe for use. It is widely used and does not cause significant effects unless taken in very high amounts, far exceeding typical usage. This indicates it is well-tolerated under normal conditions.

For HFA-152a, studies have indicated that it is also safe when inhaled. It does not cause serious side effects and is unlikely to make breathing difficult, suggesting it should be safe for use in inhalers.

Both ingredients are considered safe based on current research. However, since this trial is in its early stages, it primarily focuses on assessing safety for the first time in this specific setting. The trial aims to confirm these findings and ensure no new issues arise when used in this way. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore new propellants, HFA-134A and HFA-152A, for asthma inhalers, potentially offering eco-friendlier alternatives to traditional options. Unlike the current standard propellants, these new formulations aim to reduce environmental impact due to lower global warming potential. This shift could lead to sustainable inhaler options without compromising treatment effectiveness for asthma sufferers.

What evidence suggests that these propellants could be effective for asthma?

This trial will compare the effectiveness of two inhaler propellants for asthma: HFA-134A and HFA-152A. Research has shown that HFA-134A is effective in inhalers, performing as well as older propellants and providing a reliable option for people with asthma. Early evidence suggests that HFA-152A is as safe and effective as HFA-134A, with the added benefit of being more environmentally friendly. Both propellants are unlikely to cause breathing issues, such as airway tightening, after use. Participants in this trial will receive both propellants in different sequences to assess their effectiveness and safety. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06702462

NCT06702462 | A Study to Assess the Potential for Airway ... A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8617079/

Cumulative dose-response study of non-CFC propellant ... Conclusions: HFA 134a salbutamol sulfate and CFC 11/12 salbutamol produced clinically and statistically similar airway responses and side effects. These results ...

3. aacijournal.biomedcentral.com aacijournal.biomedcentral.com/articles/10.1186/s13223-017-0202-0

Asthma pressurised metered dose inhaler performance Table 4 shows fall in oxygen from 100% after five actuations of HFA 134a and HFA 227ea propellant pMDIs. The results of ×5 actuations of HFA ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S001236921545857X

Asthma Cumulative Dose-Response Study of Non-CFC ... These results indicate that HFA 134a salbutamol sulfate would be a safe and effective substitute for CFC 11/12 salbutamol.

5. resmedjournal.com resmedjournal.com/article/S0954-6111(00)80147-X/pdf

Clinical efficacy and safety of fluticasone propionate 250 # ... HFA 134a, is an effective treatment for patients with mild to moderate asthma. The data indicate that substitution of ozone-depleting CFCs with HFA 134a in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5492461/

Asthma pressurised metered dose inhaler performance Toxicology studies on safety for human use of HFA134a and 227ea neither appreciated nor studied the physical and pharmacological properties of ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf

proair™ hfa (albuterol sulfate) inhalation aerosol Propellant HFA-134a is devoid of pharmacological activity except at very high doses in animals (380 - 1300 times the maximum human exposure based on comparisons ...

8. inhalationmag.com inhalationmag.com/wp-content/uploads/pdf/inh_20090201_0008.pdf

HFA propellants HFA 134a accounts for the vast majority of inhaler propellants, roughly 95% of the HFA MDIs manufactured. HFA. 227ea's higher cost restricts its use to the ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0954611198902153

Safety of hydrofluoroalkane-134a beclomethasone ... The data indicate that, at doses of up to 800 μg day−1, HFA-BDP is at least as well tolerated as CFC-BDP. Other studies have found that equivalent efficacy is ...