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NCT07645248 · GlaxoSmithKline

A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)

What this study is about

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).

View original scientific description

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).

Interventions

DRUG

HFA-152a

HFA-152a will be administered.

DRUG

HFA-134a

HFA-134a will be administered.

Primary outcome measures

Number of participants with adverse events (AEs)

Time frame: Up to 8 weeks

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Participant must be aged greater than equal to (\>=)18 years at the time of signing the informed consent.
  • 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
  • ICS/SABA prn plus ICS maintenance
  • SABA prn plus ICS/ Long-acting beta agonist (LABA) maintenance
  • ICS/SABA prn plus ICS/LABA maintenance
  • SABA prn plus ICS/ Long-acting muscarinic antagonist (LAMA)/LABA maintenance (open or closed triple therapy)
  • ICS/Formoterol combination therapy as reliever therapy
  • ICS/Formoterol combination therapy as maintenance therapy plus ICS/Formoterol combination as reliever therapy.
  • Leukotriene receptor antagonist (LTRA) as add-on any of the above is permitted
  • Xanthines as add-on to any of the above permitted
  • Biological therapies indicated for the treatment of asthma as add-on to any of the above are permitted (for example, but not limited to, mepolizumab, dupilumab, tezepelumab).
  • Participants with severity of disease:
  • Baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) \>=50 percent (%) of predicted at screening.
  • Asthma Control Status
  • Asthma Control Questionnaire (ACQ)-6 score less than (\<) 1.5 at screening (and randomization).
  • Asthma that has remained stable with no severe exacerbations within the last 3 months.
  • Participants who are current non-smokers, who have not used any inhaled tobacco or vaping products within 12 months of the start of the study, and with a total pack year history of less than equal to (\<=)10 pack. The use of inhaled marijuana, even with a valid prescription, is prohibited within 12 months prior to study start.
  • Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigator or designee.
  • Male and female participants are eligible. A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
  • Is a Participant of nonchildbearing potential (PONCBP) or
  • Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1%, 30 days prior to and during the study intervention period and for at least 24 hours after the last dose of study intervention. - A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention in each Treatment Period.
  • Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF).

Exclusion criteria

  • Participants with a history of life-threatening asthma.
  • Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other significant respiratory abnormalities other than 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 severe asthma exacerbation: Defined as any asthma exacerbation requiring \>=3 days systemic corticosteroids or that resulted in overnight hospitalization or Emergency Department visit requiring additional treatment for asthma within the 3 months prior to screening.
  • Participants with Other concurrent Diseases/Abnormalities: A participant has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the study results.
  • 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.
  • Any planned or anticipated changes in asthma medications during the study period.
  • Any planned environmental changes (e.g. employment changes, travel) which, in the Investigator's opinion, could lead to e.g. increased allergen exposure.
  • 12-Lead ECG abnormality: Significant abnormality in the 12-lead ECG performed at screening.
  • Alanine transaminase (ALT) \>2 times Upper limit of normal (ULN).
  • Total bilirubin \>1.5 times ULN; For participants with Gilbert's syndrome can be included with total bilirubin \>1.5 times ULN if direct bilirubin is \<=1.5 times ULN.
  • Participants with Cirrhosis or current unstable liver or biliary disease.
  • Participants with QTc \>480 milliseconds (msec).

Where

  • Aventura, Florida
  • Miami, Florida
  • Owensboro, Kentucky
  • Columbia, Missouri
  • Henderson, Nevada
  • Medford, Oregon
  • Spartanburg, South Carolina
  • Cypress, Texas
  • Tomball, Texas

Related conditions & keywords

AsthmaBronchospasmHydrofluoroalkaneMetered dose inhalerPropellant

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations

📊
1 of 110 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Aventura

Florida

Location available
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Owensboro

Kentucky

Location available
RECRUITING

Columbia

Missouri

Location available
RECRUITING

Henderson

Nevada

Location available
RECRUITING

Medford

Oregon

Location available
RECRUITING

Spartanburg

South Carolina

Location available
RECRUITING

Spartanburg

South Carolina

Location available

And 2 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Asthma Treatment in Aventura?

Join others in Florida exploring innovative treatment options through clinical research

Asthma Treatment Options in Aventura, Florida

If you're searching for Asthma treatment in Aventura, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Aventura, Miami, Owensboro and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Asthma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 110 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Asthma?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Asthma

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Asthma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07645248. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.