Salbutamol Inhalers for Asthma

Recruiting at 139 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Inhaled corticosteroids, Short-acting beta-agonists

Must not be taking: Long-acting muscarinic antagonists, Biologics

Disqualifiers: Life-threatening asthma, Chronic liver disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

412 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and ease of use of salbutamol inhalers with different propellants for asthma treatment. Researchers are comparing two types of inhalers to determine which one people with asthma tolerate better. The trial seeks adults who have had stable asthma for at least six months and regularly use certain asthma treatments. Participants should not have experienced any severe asthma attacks or other lung diseases in the past six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to the development of a potentially new asthma treatment.

Will I have to stop taking my current medications?

The trial requires that participants stay on their current asthma medications at a stable dose, except for those using an ICS/SABA inhaler as reliever therapy, who must stop using it for the study duration.

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

Research has shown that salbutamol is generally safe for people with asthma. Studies have found that inhalers using the HFA-134a propellant, such as Proventil and Ventolin, are well-tolerated even with regular use. Users can take up to 16 puffs a day without major issues. A common side effect of salbutamol is a fast or irregular heartbeat, known as palpitations. Although this might sound concerning, it is a known effect and usually not harmful.

The current trial examines the efficacy and safety of salbutamol with a different propellant (HFA-152a) compared to the existing one (HFA-134a). As a Phase 3 trial, earlier studies have demonstrated the treatment's reasonable safety, and now it is being tested in a larger group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Researchers are excited about the salbutamol inhalers in this trial because they offer a potential new way to manage asthma symptoms more effectively. Unlike many existing asthma treatments, which focus on long-term control, salbutamol acts quickly to relieve acute symptoms by relaxing the muscles in the airways. This rapid action makes it an essential option for immediate relief during asthma attacks. Additionally, the trial is exploring both a reference and a test arm, potentially offering insights into improved formulations or delivery methods that could enhance the effectiveness or convenience of salbutamol inhalers.

What is the effectiveness track record for salbutamol in treating asthma?

Studies have shown that salbutamol effectively manages asthma symptoms. It quickly relieves asthma attacks by relaxing the muscles in the airways, improving breathing. In this trial, participants will join either the Salbutamol Reference Arm or the Salbutamol Test Arm to evaluate its effectiveness. One study found that when combined with budesonide, salbutamol reduced the risk of severe asthma attacks by 47%. However, salbutamol can also cause common side effects, such as palpitations or a rapid heartbeat (tachycardia). Overall, salbutamol is a trusted medication for controlling asthma, but awareness of these possible side effects is important. ^{1 6 7 8 9}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with stable asthma, as defined by the Global Initiative for Asthma (GINA), who have not had a severe exacerbation in the last 6 months. Participants must have controlled asthma with an ACQ score <1.5 and be able to withhold short-acting bronchodilators for at least 6 hours before testing.

Inclusion Criteria

Asthma Control Status with Asthma Control Questionnaire (ACQ) 6 score <1.5 at screening

I am 12 years or older, or my guardian has consented.

I have had asthma for at least 6 months, as per GINA guidelines.

Exclusion Criteria

I have had an asthma attack in the last 6 months.

I haven't used biologic or immunosuppressive therapies for respiratory issues in the last 6 months or 5 half-lives, whichever is longer.

I have had severe or uncontrolled asthma in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive salbutamol via metered dose inhaler containing propellant HFA-152a or HFA-134a

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Salbutamol

Trial Overview The study compares safety and tolerability of salbutamol delivered via two different propellants in inhalers: HFA-152a versus HFA-134a. It's designed to see if there's any difference between these two types of metered dose inhalers over a three-month treatment period.

How Is the Trial Designed?

Group I: Salbutamol Test Arm Experimental Treatment 1 Intervention

Group II: Salbutamol Reference Arm Active Control 1 Intervention

Salbutamol is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Ventolin for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Exercise-induced bronchoconstriction
• High blood potassium levels

Approved in United States as Albuterol/Ventolin for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Exercise-induced bronchoconstriction
• High blood potassium levels

Approved in Canada as Ventolin for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Exercise-induced bronchoconstriction
• High blood potassium levels

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

Published Research Related to This Trial

Endotracheal administration of albuterol was successfully used in a 67-year-old woman with severe asthma, leading to significant improvement in her clinical status and arterial blood gases.

This method of delivering albuterol directly to the bronchial tree is effective for intubated asthmatic patients, allowing for rapid recovery and extubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of asthma-related respiratory arrest with endotracheal albuterol (salbutamol). Verbeek, PR., Gareau, AB., Rubes, CJ.[2019]

A study involving 10 healthy volunteers found no significant differences in lung bioavailability between generic (Salamol, Salbulin) and innovator (Ventolin) formulations of inhaled salbutamol, indicating similar effectiveness in delivering the medication to the lungs.

All formulations produced comparable plasma salbutamol levels and urinary excretion rates, suggesting that both generic and innovator inhalers can be used interchangeably without loss of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung bioavailability of generic and innovator salbutamol metered dose inhalers. Clark, DJ., Gordon-Smith, J., McPhate, G., et al.[2019]

A study involving 498 adolescents and adults with mild-to-moderate asthma showed that both salmeterol powder (50 microg via Diskus) and aerosol (42 microg via MDI) significantly improved lung function (FEV1 and PEF) compared to placebo over 12 weeks.

Both formulations of salmeterol were well tolerated, with safety profiles similar to placebo, indicating that either option is effective and safe for managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. Wolfe, J., Kreitzer, S., Chervinsky, P., et al.[2015]

Inhalation of salbutamol (100 microg) significantly protects against bronchoconstriction induced by methacholine in patients with moderate asthma, regardless of the inhalation device used (pMDI, pMDI + spacer, or Autohaler).

While there was a slight trend suggesting that using a pMDI with a spacer may enhance the protective effect of salbutamol, the differences among the inhalation techniques were not statistically significant, confirming the drug's efficacy across various methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The protective effect of salbutamol inhaled using different devices on methacholine bronchoconstriction. Giannini, D., Di Franco, A., Bacci, E., et al.[2019]

In a study involving 38 patients with stable asthma, the efficacy of salbutamol was tested using six different aerosol devices, including metered-dose inhalers and various nebulizers.

The bronchodilator response was measured by FEV1 and airway conductance, providing insights into how different devices affect the delivery and effectiveness of salbutamol in improving breathing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inhalation of beta-stimulators: comparison of the effects of 6 different inhalation devices]. Rochat, T., Vonwil, A., Bachofen, H.[2013]

In a study involving 24 asthmatic patients, both HFA 134a salbutamol sulfate and CFC 11/12 salbutamol showed equivalent improvements in lung function (FEV1 and FVC) after inhalation, indicating similar efficacy.

The safety profiles of both medications were comparable, with no significant differences in heart rate, blood pressure, or adverse events, suggesting that HFA 134a salbutamol sulfate is a safe alternative to CFC 11/12 salbutamol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. Kleerup, EC., Tashkin, DP., Cline, AC., et al.[2019]

In a study involving 12 asthma patients, both pirbuterol (400 micrograms) and salbutamol (200 micrograms) were found to significantly induce bronchodilation, improving airflow in patients with stable reversible broncho-obstruction.

The study indicated that pirbuterol and salbutamol have similar efficacy in treating asthma symptoms, with minimal side effects reported, suggesting they are both safe options for bronchodilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative studies on pirbuterol, salbutamol and a placebo administered as an aerosol in asthmatic patients]. Verstraeten, JM.[2013]

In a study involving 126 children with asthma, both original salbutamol and a similar salbutamol product showed comparable bronchodilator responses, indicating no significant difference in their effectiveness for improving forced expiratory volume (FEV1).

The study found that the weight of the drops differed significantly between the two products, but this did not translate into a difference in clinical efficacy, suggesting that both formulations can be considered equally effective for treating acute asthma exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Original salbutamol versus similar salbutamol in children with asthma exacerbation: a randomized, controlled, double-blind study. Molise, MC., Maffey, AF., Ramos, P., et al.[2022]

In a study of 197 patients with mild asthma, montelukast provided superior long-term protection against exercise-induced bronchoconstriction (EIB) compared to salmeterol over an 8-week period, showing effectiveness without tolerance development.

Montelukast also resulted in fewer respiratory adverse events and discontinuations due to side effects compared to salmeterol, suggesting it may be a safer and more effective option for chronic EIB management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montelukast versus salmeterol in patients with asthma and exercise-induced bronchoconstriction. Montelukast/Salmeterol Exercise Study Group. Villaran, C., O'Neill, SJ., Helbling, A., et al.[2021]

In a 6-month study involving 455 patients with mild asthma, using a combination inhaler of beclomethasone and albuterol as needed was found to be as effective as regular use of beclomethasone, with improved morning peak expiratory flow rates and fewer exacerbations compared to using albuterol alone.

The as-needed combination therapy resulted in a significantly lower cumulative dose of inhaled beclomethasone over the 6 months, suggesting a more efficient treatment approach for managing mild asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma. Papi, A., Canonica, GW., Maestrelli, P., et al.[2022]

In a study of nine healthy subjects, intravenous salbutamol (SAL) at a dose of 20 microg/min significantly increased minute ventilation (VE) by 37.8%, along with increases in oxygen consumption (VO2) and CO2 production (VCO2), indicating that SAL raises metabolic demands.

The rise in ventilation was linked to increased serum lactate levels and a decrease in base excess, suggesting that SAL can induce lactic acidosis, which may pose risks for asthmatic patients with limited ventilatory capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms by which systemic salbutamol increases ventilation. Tobin, AE., Pellizzer, AM., Santamaria, JD.[2022]

Salmeterol and formoterol are long-acting inhaled beta2-agonists that improve lung function and quality of life in asthma patients, with effects lasting over 12 hours, making them effective for managing symptoms and preventing nighttime awakenings.

Formoterol has a rapid onset of action, while salmeterol has a delayed onset; both are safe adjuncts to inhaled corticosteroids and can help protect against exercise-induced asthma when used correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting inhaled beta2-agonists in asthma therapy. Moore, RH., Khan, A., Dickey, BF.[2019]

In a multicenter study involving children aged 5 to 18, salbutamol delivered via a pMDI with Volumatic spacer or an Easyhaler was found to be as effective as nebulized salbutamol for treating mild to moderate asthma exacerbations.

The Easyhaler group experienced significantly less tachycardia after the second dose, indicating a potential safety advantage, while no significant adverse events were reported across all treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of salbutamol efficacy in children--via the metered-dose inhaler (MDI) with Volumatic spacer and via the dry powder inhaler, Easyhaler, with the nebulizer--in mild to moderate asthma exacerbation: a multicenter, randomized study. Direkwatanachai, C., Teeratakulpisarn, J., Suntornlohanakul, S., et al.[2016]

Lipid microparticles (LMs) were successfully developed to provide a sustained release of salbutamol sulphate, a common bronchodilator for asthma, using the spray congealing technique.

The optimal formulation achieved a drug loading of 4.72% and a particle size suitable for effective delivery, indicating potential for improved asthma treatment through prolonged medication release.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of spray congealing and melt emulsification methods for the incorporation of the water-soluble salbutamol sulphate in lipid microparticles. Scalia, S., Traini, D., Young, PM., et al.[2013]

In a study involving 92 patients with stable asthma, Salmeterol (50 micrograms twice daily) provided better overall asthma control compared to Salbutamol (400 micrograms four times daily) over an 8-week period.

Most patients preferred Salmeterol, and its effectiveness was found to be independent of any concurrent inhaled steroid treatment, highlighting its potential as a reliable option for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Salmeterol improves control in asthmatic patients treated in general practice. A comparative study of salmeterol (Serevent) and salbutamol (Ventoline) in patients with mild to moderate asthma]. Staehr, P., Vestbo, I.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730473/

Safety outcomes of salbutamol: A systematic review and ... This meta‐analysis indicated that salbutamol was associated with a very common risk of palpitations or tachycardia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9420439/

A Comparison of the Effectiveness of Asthma Medications ... This real-world study showed that the effectiveness of asthma medications varied according to drug type, active ingredient, combination, and period of use.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504544

As-Needed Albuterol–Budesonide in Mild Asthma The risk of a severe exacerbation was 47% lower with albuterol–budesonide than with albuterol, which led to the trial being stopped after a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213219822008285

Effectiveness of a Digital Inhaler System for Patients With ... The primary outcome was improvement in asthma control, defined as achievement of well-controlled asthma (ACT score ≥ 20) and/or gaining a clinically meaningful ...

5. ohsu.edu ohsu.edu/sites/default/files/2019-01/QRMA_final-report_update-1_evidence-tables_unshaded_OCT_08.pdf

Drug Class Review Quick-relief Medications for Asthma Effectiveness Outcomes: Symptoms: Authors reported no statistically significant differences in percent change in clinical scores (Accessory muscle score; Wheeze ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00634517

4-Week Study of Efficacy, Safety and PK of Albuterol-HFA ... This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369216324047

Proventil HFA and Ventolin Have Similar Safety Profiles ... Proventil HFA had a similar safety profile as Ventolin during regular use. A dosage of 16 puffs per day of propellant HFA-134a was well tolerated by asthmatics.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9498941/

Proventil HFA and ventolin have similar safety profiles ... Proventil HFA had a similar safety profile as Ventolin during regular use. A dosage of 16 puffs per day of propellant HFA-134a was well tolerated by asthmatics.

9. journal.chestnet.org journal.chestnet.org/article/S0012-3692(16)32404-7/fulltext

Proventil HFA and Ventolin Have Similar Safety Profiles ... Proventil HFA had a similar safety profile as Ventolin during regular use. A dosage of 16 puffs per day of propellant HFA-134a was well tolerated by asthmatics.