Assessing airway sensitivity reactions in asthma patients using different inhaler propellants

A Randomized, Non-inferiority, Double-blind, Controlled, Single-dose, 2-way Cross-over Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Metered Dose Inhalers in Adults Aged 18-45 With Mild Asthma

This study is testing if a new inhaler propellant can be safely used by adults with mild asthma without causing breathing problems, compared to an older propellant.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: GlaxoSmithKline (industry)
• Drugs / interventions: mepolizumab, dupilumab
• Locations: 2 sites (Marlton, New Jersey and 1 other locations)
• Trial ID: NCT06702462 on ClinicalTrials.gov

What this trial studies

This study evaluates the potential airway sensitivity reactions caused by two different propellants, HFA-152a and HFA-134a, when administered through pressurized metered dose inhalers (pMDI) in adults with mild asthma. The aim is to determine if the new propellant, HFA-152a, which has a lower carbon footprint, can be safely used without causing airway tightening. Participants will be adults aged 18 to 45 with a confirmed asthma diagnosis, receiving stable asthma treatment. The study will compare the effects of both propellants on airway sensitivity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 45 with a confirmed diagnosis of asthma who have been stable on their asthma medications.

Not a fit: Patients with severe asthma or those not currently receiving stable asthma treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of a more environmentally friendly inhaler propellant that is safe for asthma patients.

How similar studies have performed: While the approach of using alternative propellants is innovative, similar studies have not been widely reported, making this a novel investigation.

Eligibility criteria

Inclusion Criteria:

Participants are eligible to be included in the study if all the following criteria apply:

* Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
* Participant must be 18 to 45 years of age inclusive, at the time of screening.
* Confirmed diagnosis of asthma: documented, established diagnosis of asthma for at least 6 months.
* Receiving 1 of the following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study:

  * As needed short-acting beta-agonists (SABA) only
  * As needed SABA plus low-dose Inhaled corticosteroids (ICS) (defined as 100-250 µg/day fluticasone propionate or equivalent taken whenever SABA is taken).
  * Daily maintenance low-dose ICS, plus as needed SABA or ICS-SABA single inhaler combination therapy
  * Low dose combination single inhaler ICS-formoterol or single inhaler ICS-SABA as needed for symptom relief (and if needed, before exercise)
  * Leukotriene receptor antagonist (LTRAs) in combination with any of the above therapies
* Asthma Control Questionnaire (ACQ)-6 score \<1.5 at screening and Day -1.
* No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
* Lung function: subjects with a pre-bronchodilator FEV1 ≥60% predicted at Screening and Day-1.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

  * Is a Woman of non-childbearing potential (WONCBP) OR
  * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1%.
* Female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 28 days before the first dose of study intervention.
* For male participants, no contraceptive measures are required.
* Non-smokers, or previous smokers who have not used any tobacco containing-products or vaping products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.
* The use of marijuana, even with a valid prescription, is prohibited within 12 months prior to study start.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
* Asthma treatment requiring use of biologic agents (e.g. mepolizumab or dupilumab), chronic systemic corticosteroids, or oral controller agents other than LTRAs.
* Respiratory disorders other than asthma; A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis and other respiratory abnormalities other than asthma that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates and/or requires additional therapy during the study. This includes history of lung cancer and previous thoracic surgery such as lung resection.
* Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening. (Severe asthma exacerbation defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or a single depo injection or an in-patient hospitalization or early discontinuation (ED) visit due to asthma that required systemic corticosteroids).
* Biologic/immunosuppressive therapies that can be used for the treatment of respiratory diseases during the 6 months, or 5 half-lives whichever is longer-prior to start of the study.
* Participants undergoing de-sensitization therapy.
* Administration of systemic, oral, or depot corticosteroids for asthma treatment within 12 weeks of Visit 1. Intranasal corticosteroids are permitted if at a stable dose for at least 3 months prior to screening.
* Stable doses (3 months or longer) of the following are permitted:

  * Intranasal corticosteroids
  * Oral anti-histamines

Where this trial is running

Marlton, New Jersey and 1 other locations

• GSK Investigational Site — Marlton, New Jersey, United States (RECRUITING)
• GSK Investigational Site — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions: Asthma, HFA-152a, HFA-134a, pMDI