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Study comparing CHF 5993 (beclometasone/formoterol/glycopyrronium) to fluticasone/salmeterol inhalation in adolescents with uncontrolled asthma on medium-dose inhaled therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on adolescents with uncontrolled asthma who are currently using inhaled medications but still experiencing symptoms. The study will compare two inhaled medications: an experimental drug called CHF5993 (which contains beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide) against an existing medication called Seretide Evohaler (which contains fluticasone propionate and salmeterol). Both medications are delivered through a pressurized inhaler device.

The main purpose of this research is to determine if CHF5993 works better than Seretide Evohaler in improving breathing function in young patients. The study will last for 52 weeks, during which participants will be randomly assigned to use either CHF5993 or Seretide Evohaler. Neither the participants nor the doctors will know which medication each person is receiving during the study. Some participants will also receive placebo inhalers as part of the study design.

Throughout the study, doctors will monitor participants' breathing ability, how well their asthma is controlled, their quality of life, and any potential side effects of the medications. They will perform various tests to measure lung function and collect information about asthma symptoms and any asthma attacks that occur during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial study period
You will start a 52-week study comparing two different asthma medications.
The study involves two groups: one receiving CHF 5993 (a combination of beclomethasone, formoterol, and glycopyrronium) and another receiving Seretide Evohaler (a combination of fluticasone and salmeterol).
Neither you nor the medical staff will know which medication you are receiving during the study.
Step 2
Medication administration
You will receive training on how to use the pressurized inhaler device correctly.
You will need to use the inhaler as prescribed throughout the study period.
You may also need to use a spacer device with your inhaler if applicable.
Step 3
Regular assessments
You will need to perform breathing tests (spirometry) during clinic visits.
You will be provided with an electronic diary to record your symptoms.
You will need to perform breathing tests at home using provided equipment.
Your blood pressure and heart activity (ECG) will be monitored during applicable visits.
Blood samples will be taken to check standard blood parameters at scheduled visits.
Step 4
Week 26 evaluation
A key assessment of your breathing capacity will be performed.
You will complete questionnaires about your asthma symptoms and quality of life.
Additional breathing tests will be conducted before and after using your medication.
Step 5
Final assessment - Week 52
Final breathing tests will be performed, including measurements 48 hours after your last dose.
Final questionnaires about your asthma symptoms and quality of life will be completed.
Final blood tests and heart monitoring will be conducted.
Your overall response to the treatment will be evaluated.

Who can join the trial?

10 criteria

You must provide written informed consent from parents/legal representatives and verbal or written agreement from the participant before any study procedures
You must be able to: - Use inhaler devices and spacer correctly - Perform breathing tests and home lung function measurements - Use an electronic diary properly
You must be between 12 and 18 years old
For specific study measurements, you must weigh at least 30 kg
You must have been diagnosed with asthma for at least 6 months
You must be currently using a combination of two medications: - A medium-dose inhaled steroid - A long-acting bronchodilator for at least 4 weeks before screening
Your lung function test (FEV1 - amount of air you can forcefully exhale in one second) must be between 60% and 90% of normal predicted value
You must show improvement in breathing tests after using a rescue inhaler (salbutamol), with at least 12% increase and 200mL improvement in lung function
Your asthma must be considered uncontrolled, with a score of 1.5 or higher on the ACQ-7 (Asthma Control Questionnaire)
You must have had at least one asthma flare-up in the past 12 months that required: - Steroid tablets/injections, or - Emergency room visit, or - Hospital stay

Who cannot join the trial?

13 criteria

History of severe or uncontrolled asthma (a respiratory condition where airways become inflamed and narrow)
Patients younger than 18 years of age
Patients who have participated in another clinical trial within the past 30 days
Current smokers or those who quit smoking less than 6 months ago
Known allergies or hypersensitivity to any of the study medications or their components
Significant heart, liver, or kidney disease that is not well controlled
Recent respiratory tract infection (within 4 weeks before starting the study)
Use of prohibited medications that might interfere with the study results
Pregnancy or breastfeeding women
Inability to use the inhaler device properly
Any condition that the study doctor believes would make participation unsafe
Mental conditions that could interfere with following study procedures
History of alcohol or drug abuse within the past 12 months

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

A.O.U. Policlinico G. Martino Di Messina
Verified
Messina, Italy
ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy

Trial locations

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Investigated drugs

CHF 5993
is a combination inhaler containing three medications that help control asthma symptoms. It contains beclomethasone (a corticosteroid that reduces airway inflammation), formoterol (a long-acting medication that helps open the airways), and glycopyrronium (a medication that helps relax airway muscles). This inhaler delivers the medicine in very fine particles to reach deep into the lungs.
Seretide Evohaler
is a combination inhaler containing two medications for asthma control. It combines fluticasone (a corticosteroid that reduces inflammation in the airways) and salmeterol (a long-acting medication that helps keep airways open). This inhaler is commonly used to treat asthma symptoms and help prevent asthma attacks.

What is already known about the treatment

CHF 5993 (Beclomethasone/Formoterol/Glycopyrronium)
A pressurized metered-dose inhaler (pMDI) combining three active ingredients: beclomethasone dipropionate (a corticosteroid), formoterol fumarate (a long-acting beta-2 agonist), and glycopyrronium bromide (a long-acting muscarinic antagonist). This triple combination therapy is being investigated for uncontrolled asthma in adolescents who haven't achieved adequate control with medium-dose inhaled corticosteroids plus long-acting beta-2 agonists. The medication works by reducing airway inflammation, relaxing airway muscles, and preventing bronchial constriction.
Seretide Evohaler (Fluticasone/Salmeterol)
A pressurized metered-dose inhaler combining fluticasone propionate (a corticosteroid) and salmeterol xinafoate (a long-acting beta-2 agonist). This established dual combination therapy is used in the treatment of asthma, delivered through an inhaler device for direct administration to the airways. The medication works by reducing inflammation in the airways while simultaneously providing long-acting bronchodilation to help improve breathing in patients with asthma.

Investigated diseases

Uncontrolled Asthma - A chronic respiratory condition characterized by persistent inflammation and narrowing of the airways that is not adequately managed with standard asthma treatments. The condition involves frequent breathing difficulties, wheezing, chest tightness, and coughing that occur throughout the day and night. Patients experience regular asthma symptoms despite using their prescribed maintenance medications. The airways remain hypersensitive to various triggers, leading to recurring episodes of airway constriction. People with uncontrolled asthma often have limitations in their daily activities and may experience frequent flare-ups of their symptoms.