Ongoing Clinical Trials for Bronchostenosis
Currently, there is 1 ongoing clinical trial related to bronchostenosis, examining the safety of asthma treatments using salbutamol inhalers with different propellants. This trial is being conducted across multiple European countries.
Clinical trial locations
- France
- Greece
- Italy
- Poland
- Spain
Study on the Safety of Salbutamol Inhalers with Propellants HFA-152a and HFA-134a for Adults with Asthma
This trial is investigating the long-term safety and tolerability of salbutamol sulfate inhalers over a three-month period. The study compares two different inhaler propellants: a new propellant called HFA-152a and the standard propellant HFA-134a. Both are designed to help relieve symptoms by opening up the airways, making breathing easier.
Main Inclusion Criteria:
- Participants must be at least 18 years old
- Must have a documented history of asthma for at least 6 months
- Should be on stable asthma treatment for at least 12 weeks before the study begins
- Asthma should be well-controlled with no severe worsening in the past 6 months
- Lung function test (FEV1) must show at least 60% of the predicted value
- Must demonstrate airway reversibility, meaning lung function improves by at least 12% and 200 mL after using a short-acting inhaler
- Should be able to avoid using short-acting inhalers for at least 6 hours and long-acting inhalers for 24 hours before lung function tests
Main Exclusion Criteria:
- People under 18 years of age
- Those without a diagnosis of asthma
- Individuals unable to use an inhaler correctly
- People with other serious health conditions that might interfere with the study
- Pregnant or breastfeeding women
- Those who have recently participated in another clinical trial
- Individuals with known allergies to the study medication or its ingredients
- People unable to follow study procedures or attend scheduled visits
Study Focus:
The trial aims to evaluate the safety of salbutamol inhalers using the new HFA-152a propellant compared to the standard HFA-134a propellant. Participants will be randomly assigned to use one of the two inhalers as rescue medication for asthma symptoms over a 3-month period. Neither the participants nor the researchers will know which type of inhaler is being used, ensuring unbiased results. Regular check-ups will monitor participants’ health and any side effects throughout the study.
Investigational Drug:
Salbutamol is the medication being studied. It works as a bronchodilator, specifically a beta-2 adrenergic agonist, which means it relaxes the muscles in the airways to improve airflow to the lungs. It provides quick relief from asthma symptoms such as wheezing, coughing, and shortness of breath. In this trial, salbutamol is delivered through a metered dose inhaler with two different propellants to evaluate their long-term safety profiles.
Summary
There is currently one ongoing clinical trial examining treatments related to bronchostenosis and asthma. The study is being conducted across five European countries: France, Greece, Italy, Poland, and Spain. The trial focuses on evaluating the safety of salbutamol inhalers with different propellants, particularly comparing a newer propellant (HFA-152a) against the standard option (HFA-134a). This research could potentially lead to improved inhaler options for people managing respiratory conditions. The study specifically targets adults with well-controlled asthma who have been on stable treatment regimens.
