Study on Glycopyrronium Bromide for Children Aged 6-12 with Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called glycopyrronium bromide in children aged 6 to less than 12 years who have asthma. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The study aims to evaluate how well this medication works, how it moves through the body, and its safety and tolerability in children. The medication is administered as an inhalation powder using a device called a Breezhaler, which helps deliver the medicine directly to the lungs.

Participants in the study will receive different treatments over several weeks. These treatments include the active medication glycopyrronium bromide, as well as other medications like fluticasone propionate, salbutamol, and salmeterol xinafoate, which are also used to manage asthma symptoms. A placebo, which looks like the active medication but does not contain any active ingredients, will also be used for comparison. The study is designed to be double-blind, meaning neither the participants nor the researchers know which treatment is being given at any time, to ensure unbiased results.

The trial will take place over several periods, with each period lasting a few weeks. During these periods, the children will receive different treatments and their lung function will be measured to see how the medication affects their breathing. The study will also monitor any side effects or changes in health that occur during the trial. The goal is to determine the best dose and treatment plan for managing asthma in children, ensuring both effectiveness and safety.

1 joining the study

Upon joining the study, the participant will be assigned to one of the treatment groups. The study is designed to evaluate the effects of glycopyrronium bromide in children with asthma.

The study involves multiple treatment periods, each lasting for two weeks.

2 treatment period 1

During the first treatment period, the participant will receive one of the following: fluticasone propionate, salbutamol, glycopyrronium bromide, salmeterol xinafoate, or a placebo. All medications are administered via inhalation.

The participant will use the inhaler as instructed, ensuring proper technique. The dosage and frequency will be specified by the study team.

3 evaluation at week 2

At the end of the two-week period, the participant’s lung function will be assessed. This includes measuring the forced expiratory volume in one second (FEV1), which helps evaluate the effectiveness of the treatment.

Additional assessments may include monitoring for any side effects and recording any changes in asthma symptoms.

4 crossover to next treatment

After the evaluation, the participant will switch to the next treatment in the sequence. This process is repeated for each treatment period, allowing for a comprehensive assessment of each medication’s effects.

The study is designed to ensure that each participant receives all treatments, including the placebo, at different times.

5 completion of study

Upon completing all treatment periods, the participant will undergo a final evaluation to assess overall changes in asthma control and any long-term effects of the medications.

The study aims to provide valuable information on the safety and effectiveness of glycopyrronium bromide and other treatments in managing asthma in children.

Who Can Join the Study?

Children, both boys and girls, aged 6 to less than 12 years old, who have asthma.
Girls who can have children and might become sexually active must use effective birth control methods during the study. These methods include using a condom or a special cap with a sperm-killing product, or using hormonal birth control like pills, injections, or implants.
Must have a confirmed diagnosis of asthma for at least 6 months before joining the study.
Parents or legal guardians must sign a consent form, and the child must agree to participate if required by local rules.
The child must be on a stable dose of inhaled medication for asthma, with one additional controller medication, for at least 4 weeks before starting the study.
The child’s lung function, measured by a test called FEV1, must be between 60% and 90% of what is expected for their age and size at the start of the study.
The child must show improvement in lung function after using a bronchodilator (a medicine that helps open the airways) during the study. If this improvement is not shown initially, it can be tested again within 5 days. If still not shown, past medical records showing improvement can be used.
The child must be able to use inhalers correctly and complete breathing tests before starting the study.
A parent or legal guardian must be available to help the child with study tasks, like filling out an electronic diary and attending all study visits.
Parents or legal guardians must be willing and able to help the child follow the study procedures, such as taking the study medication and completing the electronic diary.

Who Cannot Join the Study?

Patients with any other lung disease besides asthma.
Patients who have had a recent lung infection.
Patients who are currently smoking or have smoked in the past year.
Patients who have a history of severe allergies or allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who are unable to perform breathing tests required for the study.
Patients who have participated in another clinical trial within the last month.
Patients who have a history of drug or alcohol abuse.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse	Ruse	Bulgaria
Spiroped Szigetvar Kft.	Szigetvar	Hungary
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Clinexpert Kft.	Budapest	Hungary
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Semmelweis University	Budapest	Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Medical Center 1 Sevlievo EOOD	Sevlievo	Bulgaria
Wqwdvhayopw Wgqnjtrkiitufbbmnsap Cablopz Oquqjgxzj I Tanrjjntqhudu Iy Meypcbtqsbr W Lurxq	Lodz	Poland
Kygxdoii Dhrfssal Kydykb	Nagykanizsa	Hungary
Pffz Tiehn Hwkiqiph Ujtsteimrkrz	Sabadell	Spain
Hdedwbfe Vzsn dtljreaq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	29.08.2022
Hungary	Recruiting	29.08.2022
Poland	Recruiting	29.08.2022
Spain	Recruiting	29.08.2022

Trial locations

Investigated drugs:

Glycopyrronium: This medication is being tested to see how well it helps children with asthma. It works by relaxing the muscles in the airways, making it easier to breathe. The trial aims to find out how effective and safe it is for children aged 6 to less than 12 years.

Investigated diseases:

Asthma

Asthma – Asthma is a chronic condition that affects the airways in the lungs, causing them to become inflamed and narrow. This leads to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The progression of asthma can vary, with some individuals experiencing mild symptoms that occur infrequently, while others may have more severe symptoms that require regular management. Asthma symptoms can be triggered by various factors, including allergens, exercise, cold air, and respiratory infections. Over time, if not managed properly, asthma can lead to persistent inflammation and airway remodeling, which may affect lung function. Regular monitoring and avoiding triggers are important in managing the progression of asthma.

Trial ID:

2024-511382-11-00

Protocol code:

CQVM149C2201

NCT ID:

NCT05222529

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Glycopyrronium Bromide for Children Aged 6-12 with Asthma

What is this study about?

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