What is the mechanism of action of this treatment?

Asthma treatments commonly include bronchodilators such as Salbutamol, which work by relaxing the muscles around the airways, leading to their dilation and improved airflow. This rapid relief of bronchoconstriction is crucial for asthma patients as it helps alleviate acute symptoms like shortness of breath and wheezing. Long-acting bronchodilators (LABAs) and inhaled corticosteroids (ICS) are also used to manage chronic symptoms and reduce inflammation, respectively. Understanding these mechanisms is vital for asthma patients to effectively manage their condition and prevent exacerbations.

What side effects are associated with this type of intervention?

Common treatments for asthma, such as short-acting beta agonists (SABAs) like Salbutamol, can have side effects including tremors, nervousness, headache, tachycardia (rapid heart rate), and palpitations. Inhaled corticosteroids, another common treatment, may cause oral thrush, hoarseness, and coughing. Long-acting beta agonists (LABAs) can have similar side effects to SABAs but are used for longer-term control. Combination inhalers that include both LABAs and corticosteroids may combine these side effects. It is important to use these medications as prescribed and discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several bronchodilators for the treatment of asthma, focusing on both short-acting and long-acting beta-agonists. Short-acting beta-agonists (SABAs) like albuterol (also known as salbutamol) and levalbuterol are commonly used for quick relief of asthma symptoms by relaxing airway muscles. Long-acting beta-agonists (LABAs) such as salmeterol and formoterol are used for long-term control and prevention of asthma symptoms. These medications are often combined with inhaled corticosteroids for enhanced efficacy in managing chronic asthma.

What other types of research exist?

A promising novel alternative to Salbutamol for asthma patients is the plant-based formulation DCBT4567-Astha-15. In a controlled clinical trial, it was compared with oral Salbutamol, Salbutamol + Theophylline, and a placebo, showing efficacy in patients with reversible asthma. This formulation could offer a new treatment option for asthma patients in 2024.

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Bronchodilator

Salbutamol Methods for Asthma

Phase 4

Waitlist Available

Led By Don Cockcroft, MD

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-60 minutes

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will compare different ways of using salbutamol to treat airway narrowing caused by methacholine.

Who is the study for?

This trial is for adults with asthma who have a stable lung function (FEV1 ≥ 65% predicted) and react to methacholine, a substance used in breathing tests. Participants should not be pregnant, breastfeeding, smokers, or have had respiratory infections or exposure to asthma triggers within the last month.

What is being tested?

The study aims to compare how effective two forms of salbutamol are at reversing constriction caused by methacholine: one delivered through an inhaler with a spacer and the other via a nebulizer. A placebo group is also included for comparison.

What are the potential side effects?

Salbutamol may cause side effects like tremors, headache, fast heart rate, and muscle cramps. The severity can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lung function recovery

Secondary study objectives

Heart rate

Time to lung function recovery

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: salbutamol delivered with vibrating mesh nebulizerExperimental Treatment1 Intervention

200microliters of salbutamol will be administered using a vibrating mesh nebulizer

Group II: salbutamol delivered via pressurized metered dose inhalerActive Control1 Intervention

200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer

Group III: placeboPlacebo Group1 Intervention

normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments commonly include bronchodilators such as Salbutamol, which work by relaxing the muscles around the airways, leading to their dilation and improved airflow. This rapid relief of bronchoconstriction is crucial for asthma patients as it helps alleviate acute symptoms like shortness of breath and wheezing. Long-acting bronchodilators (LABAs) and inhaled corticosteroids (ICS) are also used to manage chronic symptoms and reduce inflammation, respectively. Understanding these mechanisms is vital for asthma patients to effectively manage their condition and prevent exacerbations.

Short-acting inhaled bronchodilators for cystic fibrosis.Clinical efficacy with formoterol in the absence of a response to salmeterol: a review.