Salbutamol Inhalers for Asthma

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma

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.

What data supports the effectiveness of the drug Salbutamol for asthma?

Research shows that Salbutamol is effective in treating asthma symptoms, especially during acute asthma attacks. It is often used as a quick-relief medication to help open airways and make breathing easier. ^{1 2 3 4 5}

Is salbutamol safe for humans?

Salbutamol, also known as Albuterol and other names, is generally considered safe for humans with few side effects when used as an inhaler for asthma. Studies have shown it effectively helps with breathing and has a good safety record. ^{6 7 8 9 10}

How is the drug Salbutamol unique for treating asthma?

Salbutamol is unique because it can be administered through various inhalation devices, including metered-dose inhalers and nebulizers, providing flexibility in treatment. It is also effective when delivered endotracheally in severe cases, offering a rapid response for patients with critical asthma symptoms. ^{11 12 13 14 15}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Salbutamol (Beta-2 Agonist)

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.

Participant Groups

Group I: Salbutamol Test Arm Experimental Treatment 1 Intervention

Group II: Salbutamol Reference Arm Active Control 1 Intervention

Salbutamol is already approved in Canada for the following indications:

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

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Denmark 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]. [2015]

2. Argentina pubmed.ncbi.nlm.nih.gov

Original salbutamol versus similar salbutamol in children with asthma exacerbation: a randomized, controlled, double-blind study. [2022]

3. Thailand 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. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Montelukast versus salmeterol in patients with asthma and exercise-induced bronchoconstriction. Montelukast/Salmeterol Exercise Study Group. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Mechanisms by which systemic salbutamol increases ventilation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

The protective effect of salbutamol inhaled using different devices on methacholine bronchoconstriction. [2019]

9. Belgium pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Long-acting inhaled beta2-agonists in asthma therapy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of asthma-related respiratory arrest with endotracheal albuterol (salbutamol). [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Inhalation of beta-stimulators: comparison of the effects of 6 different inhalation devices]. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. [2019]

14. England 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. [2013]

15. England pubmed.ncbi.nlm.nih.gov

Lung bioavailability of generic and innovator salbutamol metered dose inhalers. [2019]