#1 Clinical Trials Search in Europe

Salbutamol Sulfate Ph. Eur.

This article examines clinical trials investigating the use of Salbutamol Sulfate Ph. Eur. in patients with severe eosinophilic asthma. Salbutamol Sulfate, also known as albuterol, is a short-acting beta-2 agonist commonly used as a rescue inhaler for asthma symptoms. The trials aim to assess its efficacy and safety when used alongside other asthma medications in patients with this severe form of asthma characterized by high levels of eosinophils, a type of white blood cell.

Table of Contents

What is Salbutamol Sulfate?

Salbutamol Sulfate, also known as Albuterol Sulfate, is a medication primarily used to treat asthma and other respiratory conditions[1]. It belongs to a class of drugs called short-acting beta-2 agonists (SABAs). In the context of severe eosinophilic asthma, Salbutamol Sulfate plays a crucial role in managing symptoms and improving lung function.

How Does It Work?

Salbutamol Sulfate works by relaxing the smooth muscles in the airways, which leads to bronchodilation – the widening of the bronchi and bronchioles in the lungs[1]. This action helps to relieve bronchospasm, reduce wheezing, and improve breathing in patients with asthma. The medication specifically targets beta-2 receptors in the lungs, providing quick relief from asthma symptoms.

Uses and Benefits

The primary uses and benefits of Salbutamol Sulfate in severe eosinophilic asthma include:

  • Quick relief of asthma symptoms such as wheezing, shortness of breath, and chest tightness
  • Prevention of exercise-induced bronchospasm
  • Use as a rescue medication during asthma attacks
  • Improvement in lung function, as measured by FEV1 (Forced Expiratory Volume in 1 second)[1]

In clinical trials, Salbutamol Sulfate has been used as a standard medication to assess bronchodilator reversibility, which is an important criterion for diagnosing and evaluating asthma[2].

Administration

Salbutamol Sulfate is typically administered through inhalation. The specific product mentioned in the clinical trials is “Sultanol Dosier-Aerosol 100 Mikrogramm/Dosis Druckgasinhalation, Suspension,” which is a pressurized inhalation suspension[1]. This form of administration allows the medication to be delivered directly to the lungs, where it can act quickly to relieve asthma symptoms.

The typical dosage used in clinical trials for assessing bronchodilator reversibility is 400 μg (micrograms), which is usually administered as four puffs of 100 μg each[2]. However, the exact dosage may vary depending on individual patient needs and should be determined by a healthcare professional.

Potential Side Effects

While Salbutamol Sulfate is generally well-tolerated, it may cause some side effects. Common side effects may include:

  • Tremors
  • Nervousness
  • Headache
  • Rapid heartbeat
  • Throat irritation

It’s important to discuss any side effects with your healthcare provider.

Precautions and Considerations

When using Salbutamol Sulfate, patients should be aware of the following:

  • Overuse of short-acting beta-2 agonists like Salbutamol Sulfate can lead to decreased effectiveness over time
  • Patients with certain heart conditions should use this medication with caution
  • It’s important to follow the prescribed dosage and not exceed the recommended amount
  • Inform your doctor if you’re pregnant, planning to become pregnant, or breastfeeding

Ongoing Research

While Salbutamol Sulfate is an established medication for asthma treatment, ongoing research continues to explore its role in severe eosinophilic asthma. In recent clinical trials, such as the EXHALE-3 study, Salbutamol Sulfate has been used as a standard medication to assess lung function and bronchodilator reversibility in patients with severe eosinophilic asthma[2].

These studies aim to better understand the effectiveness of new treatments for severe eosinophilic asthma by comparing them to established medications like Salbutamol Sulfate. This ongoing research helps to improve our understanding of asthma management and may lead to more effective treatment strategies in the future.

Aspect Details
Study Type Randomized, double-blind, placebo-controlled, parallel-group
Primary Objective Assess efficacy of dexpramipexole in reducing severe asthma exacerbations
Secondary Objectives Evaluate effects on pulmonary function, asthma control, quality of life, and blood eosinophils
Participant Criteria Age ≥12 years (≥18 in EU), diagnosed asthma for ≥12 months, high eosinophil count, history of exacerbations
Treatment Duration 52 weeks of treatment + 4 weeks follow-up
Salbutamol Sulfate Role Used as rescue medication throughout the study
Primary Endpoint Annualized rate of severe asthma exacerbations over 52 weeks
Key Secondary Endpoints Changes in FEV1, ACQ-6 scores, and AQLQ+12 scores

FAQ

  • What is severe eosinophilic asthma? Severe eosinophilic asthma is a type of asthma characterized by high levels of eosinophils (a type of white blood cell) in the blood and airways. It is often more difficult to control and may not respond well to standard asthma treatments.
  • How is Salbutamol Sulfate used in these clinical trials? In these trials, Salbutamol Sulfate is used as a rescue medication. It is administered via a pressurized inhalation device to provide quick relief of asthma symptoms when needed.
  • What are the main objectives of these clinical trials? The main objectives are to assess the efficacy of the primary study drug (dexpramipexole) in reducing severe asthma exacerbations, improving lung function, enhancing asthma control, and evaluating its effect on blood eosinophil levels. Salbutamol Sulfate is used as a standard rescue medication in this context.
  • Who can participate in these clinical trials? Participants must be 12 years or older (18 years or older in the EU), have a documented diagnosis of asthma for at least 12 months, meet specific criteria for eosinophil counts, and have a history of asthma exacerbations despite using inhaled corticosteroids and other controller medications.
  • How long do these clinical trials last? The main treatment phase of these trials lasts for 52 weeks, followed by a 4-week follow-up period. During this time, participants receive either the study drug or a placebo, while continuing to use their regular asthma medications, including Salbutamol Sulfate as needed.

Ongoing Clinical Trials on Salbutamol Sulfate Ph. Eur.

  • Study on the Effects of Dexpramipexole for Adolescents and Adults with Severe Eosinophilic Asthma

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

  • Study on the Effects of Dexpramipexole for Adolescents and Adults with Severe Eosinophilic Asthma

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Croatia Czechia France Germany Hungary +3

Glossary

  • Eosinophilic asthma: A type of asthma characterized by high levels of eosinophils (a type of white blood cell) in the blood and airways, often associated with more severe symptoms and difficulty in treatment.
  • Salbutamol Sulfate: Also known as albuterol, it is a short-acting beta-2 agonist used as a quick-relief medication for asthma symptoms. It works by relaxing the muscles in the airways to improve breathing.
  • Exacerbation: A worsening of asthma symptoms that may require additional treatment, such as oral corticosteroids, emergency care, or hospitalization.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function that indicates how much air a person can forcefully exhale in one second.
  • Inhaled corticosteroids (ICS): Anti-inflammatory medications inhaled directly into the lungs to reduce airway inflammation and prevent asthma symptoms.
  • Long-acting beta-2 agonist (LABA): A type of inhaled medication that helps to keep the airways open for an extended period, usually used in combination with inhaled corticosteroids for asthma control.
  • Bronchodilator: A medication that relaxes the muscles around the airways, making it easier to breathe. Salbutamol Sulfate is a type of bronchodilator.
  • Placebo: An inactive substance that looks like the real medication but has no therapeutic effect, used in clinical trials to compare against the active treatment.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo.
  • Asthma Control Questionnaire (ACQ): A standardized set of questions used to assess how well a person's asthma symptoms are controlled.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-dexpramipexole-for-adolescents-and-adults-with-severe-eosinophilic-asthma-3/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-dexpramipexole-for-adolescents-and-adults-with-severe-eosinophilic-asthma-2/