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Ipratropium Bromide Monohydrate

This article discusses a clinical trial investigating the use of Ipratropium Bromide Monohydrate in combination with salbutamol for treating moderate asthma attacks in children. The study aims to determine if salbutamol alone is as effective as the combination therapy in managing acute asthma exacerbations in pediatric emergency departments.

Table of Contents

What is Ipratropium Bromide Monohydrate?

Ipratropium Bromide Monohydrate is a medication used to treat respiratory conditions, particularly asthma. It belongs to a class of drugs known as anticholinergics or antimuscarinic bronchodilators. These medications work by relaxing and opening up the airways in the lungs, making it easier to breathe.[1]

Medical Uses

The primary use of Ipratropium Bromide Monohydrate is in the treatment of asthma, especially during acute exacerbations or attacks. An asthma attack is a sudden worsening of asthma symptoms that can make breathing difficult. In the clinical trial described, the medication is being studied for its effectiveness in treating moderate acute asthmatic exacerbations in children.[1]

How is it Administered?

Ipratropium Bromide Monohydrate is typically administered through inhalation. The specific product mentioned in the clinical trial is called “ATROALDO,” which is a pressurized inhalation solution. This means the medication is delivered as a fine mist that you breathe in, allowing it to reach directly into your lungs where it’s needed.[1]

Current Clinical Trial

A Phase III clinical trial is currently being conducted to evaluate the effectiveness of Ipratropium Bromide in combination with another medication called salbutamol. Here are the key points about this study:[1]

  • It’s a double-blind, randomized, controlled, non-inferiority trial. This means neither the patients nor the doctors know who’s receiving which treatment, and it’s designed to see if one treatment is not worse than another.
  • The study aims to compare salbutamol alone versus salbutamol plus Ipratropium Bromide in treating moderate asthma attacks in children.
  • The main goal is to determine if using salbutamol alone is not inferior to using it in combination with Ipratropium Bromide in reducing hospital admissions for children with moderate asthma attacks.
  • The study includes children from 1 to 18 years old with moderate asthma exacerbations.

Dosage Information

According to the clinical trial information, the maximum daily dose of Ipratropium Bromide Monohydrate is 800 micrograms. However, it’s important to note that this is the maximum dose used in the study and may not reflect the typical prescribed dose. Always follow your doctor’s instructions regarding medication dosage.[1]

Precautions and Contraindications

The clinical trial information provides some insights into when Ipratropium Bromide should not be used. These situations include:[1]

  • Patients with a history of hypersensitivity (allergic reaction) to Ipratropium Bromide
  • Individuals with narrow-angle glaucoma (an eye condition)
  • Patients with pre-existing obstruction of the urinary outflow tract
  • Pregnant or breastfeeding women
  • Patients with certain neuromuscular diseases affecting respiratory capacity
  • Individuals with specific chronic respiratory conditions like cystic fibrosis

It’s crucial to inform your healthcare provider about all your medical conditions and medications before starting treatment with Ipratropium Bromide Monohydrate.

Aspect Details
Study Type Phase III, double-blind, randomized, controlled, non-inferiority clinical trial
Main Objective Compare salbutamol alone to salbutamol plus Ipratropium Bromide in treating moderate asthma attacks in children
Primary Endpoint Reduction in hospital admission rates
Participant Age Range 1 to 18 years old
Study Duration Approximately 24 months (12 months for patient recruitment)
Treatment Comparison Salbutamol monotherapy vs. Salbutamol + Ipratropium Bromide combination
Setting Pediatric Emergency Departments

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to determine if using salbutamol alone is as effective as combining it with Ipratropium Bromide in treating moderate asthma attacks in children, specifically in reducing hospital admission rates.
  • Who can participate in this study? Children aged 1 to 18 years old with moderate asthma exacerbations can participate, provided they meet specific criteria and their parents or guardians give informed consent.
  • What is Ipratropium Bromide Monohydrate? Ipratropium Bromide Monohydrate is a medication used in inhalers to help open up airways in the lungs. In this study, it's being tested in combination with salbutamol for treating asthma attacks.
  • How long will the study last? The overall duration of the study is estimated to be about 24 months, including study design and publication. The patient recruitment period will last about 12 months.
  • What are some reasons a child might not be able to participate in this study? Children who have received Ipratropium Bromide in the previous 24 hours, have pneumonia, neuromuscular diseases affecting breathing, are immunocompromised, or have certain chronic respiratory conditions cannot participate. Also, those with urinary tract obstruction, narrow-angle glaucoma, or hypersensitivity to Ipratropium Bromide are excluded.

Ongoing Clinical Trials on Ipratropium Bromide Monohydrate

  • Study on Salbutamol and Ipratropium Bromide for Treating Moderate Asthma Attacks in Children

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Asthma exacerbation: A worsening of asthma symptoms that may require additional treatment or emergency care.
  • Bronchodilator: A medication that helps to relax and open the airways in the lungs, making breathing easier.
  • Double-blind study: A research method where neither the participants nor the researchers know who is receiving which treatment, to prevent bias.
  • Ipratropium Bromide Monohydrate: A medication used to open airways in the lungs, often used to treat breathing problems like asthma.
  • Non-inferiority trial: A type of study that aims to show that a new treatment is not worse than the standard treatment by more than a pre-specified amount.
  • Pulmonary Score: A scoring system used to assess the severity of asthma symptoms in children.
  • Randomized controlled trial: A study where participants are randomly assigned to different treatment groups to compare outcomes.
  • Salbutamol: A medication commonly used to relieve asthma symptoms by relaxing the muscles in the airways.

References

  1. http://clinicaltrials.eu/trial/study-on-salbutamol-and-ipratropium-bromide-for-treating-moderate-asthma-attacks-in-children/