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Comparing safety of two inhalers for asthma treatment

A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a

Phase 3 Interventional GlaxoSmithKline · NCT06261957

This study is testing which of two inhalers is safer for adults with asthma by comparing how well they work over three months.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment412 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations106 sites (North Hollywood, California and 105 other locations)
Trial IDNCT06261957 on ClinicalTrials.gov

What this trial studies

This study aims to assess and compare the safety and tolerability of salbutamol delivered via metered dose inhalers (MDI) using two different propellants: HFA-152a and HFA-134a. Participants aged 18 and older with a documented history of asthma will receive treatment for three months. The study will evaluate how well each inhaler performs in terms of safety and tolerability among individuals with asthma. The findings could help determine the most effective inhaler option for asthma management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with asthma for at least six months and are currently on stable asthma medication.

Not a fit: Patients who do not have a history of asthma or are not currently receiving asthma treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved inhaler options for asthma patients, enhancing their treatment experience and outcomes.

How similar studies have performed: Other studies have shown success in comparing inhaler propellants, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant of ≥18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian.
2. Asthma for ≥ 6 months, defined as:

   * Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023\]
   * Receiving one of the following asthma treatments, at a stable dose (applicable to daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA), and ICS/LABA/Long-acting muscarinic antagonist \[LAMA\]), for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study:

     * Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for asthma symptoms
     * Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the 2023 GINA guidelines \[GINA, 2023\], plus Short-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipated to remain stable for the duration of the study.
     * Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the GINA guidelines \[GINA, 2023\] plus SABA, which is anticipated to remain stable for the duration of the study.
     * Daily maintenance ICS/LABA/LAMA (low to medium dose ICS defined as 100-500 µg/day fluticasone propionate or equivalent as defined in the GINA guidelines \[GINA, 2023\] plus SABA, which is anticipated to remain stable for the duration of the study.
     * Participants who utilize combination budesonide/formoterol as reliever therapy, whether or not this is in addition to a SABA - are not eligible for screening.
     * Participants who utilize ICS/SABA combination therapy as reliever therapy, in addition to low to medium dose ICS or ICS/LABA as maintenance, are only eligible if they agree to discontinue their ICS/SABA inhaler for the duration of the study (screening through follow-up).
3. Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1)
4. Asthma Control Status

   * Asthma Control Questionnaire (ACQ) 6 score \<1.5 at screening
   * Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as:

     * Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR
     * An inpatient hospitalization or Emergency Department (ED) visit because of asthma, requiring systemic corticosteroids.
5. Evidence of reversibility of disease: Airway reversibility is defined as ≥12 percent (%) and ≥200 milliliter (mL) increase in FEV1 within 20 to 60 minutes following up to 4 inhalations of albuterol/salbutamol aerosol.
6. Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):

   * With a documented history of reversibility (as defined above) within 2 years will meet this inclusion criterion. Pre- and post-bronchodilator measurements will still be collected at screening to characterize the degree of reversibility.
   * Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period.

     * SABA should be withheld for ≥6 hours
     * Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
7. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:

   * Do not need to demonstrate reversibility in accordance with the above definition during the screening period. A reversibility maneuver will be performed to characterize the degree of post-bronchodilator change.

     * SABA should be withheld for ≥6 hours
     * LABA- and LAMA-containing medications should be withheld for \>=24 hours for the characterization of post-bronchodilator change.

Participants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry.

Exclusion Criteria:

1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
2. Other significant pulmonary diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma.
3. 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 that led to a change in asthma management, OR in the opinion of the Investigator, is expected to affect the participant's asthma status, OR the participant's ability to participate in the study.
4. Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening.
5. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study.

Where this trial is running

North Hollywood, California and 105 other locations

+56 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaSalbutamolMDIHFA-152aHFA-134a
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.