Not recruiting

Study on the Effectiveness and Safety of Budesonide, Glycopyrronium, and Formoterol Inhaler for Adults and Adolescents with Severe Asthma

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for people with severe asthma that is not well controlled with standard care. The treatment being tested is a combination of three medications: Budesonide, Glycopyrronium, and Formoterol Fumarate, delivered through an inhaler. The study will compare this new combination inhaler to other treatments, including a combination of Budesonide and Formoterol Fumarate inhaler, and a product called Symbicort, which is also an inhaler containing Budesonide and Formoterol Fumarate. A placebo inhaler, which looks like the real inhaler but does not contain active medication, will also be used in the study.

The purpose of the study is to evaluate how well the new combination inhaler improves lung function and reduces asthma attacks compared to the other treatments. Participants in the study will use the inhalers over a period of 24 to 52 weeks. During this time, they will visit the study center regularly for check-ups and assessments. The study will help determine if the new inhaler is more effective in managing asthma symptoms and preventing severe asthma attacks.

In addition to the inhalers, some participants may also use other medications like Salbutamol, which is a fast-acting inhaler used for quick relief of asthma symptoms, and Prednisolone, a tablet used to treat severe asthma attacks. The study aims to provide valuable information on the safety and effectiveness of the new inhaler combination for people with severe asthma.

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
Randomization
Upon joining the study, participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being tested.
Step 2
Treatment administration
Participants receive one of the following treatments: Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate MDI, or Symbicort pressurized MDI.
The medications are administered through inhalation. The specific dosage and frequency are determined by the study protocol and are followed throughout the trial period.
Step 3
Monitoring and assessments
Participants undergo regular monitoring to assess lung function and the effect of the treatment on asthma symptoms. This includes measuring the forced expiratory volume (FEV1) to evaluate breathing capacity.
Participants are required to maintain a daily electronic diary (eDiary) to record their symptoms and medication use, ensuring compliance with the study requirements.
Step 4
Follow-up visits
Scheduled follow-up visits occur throughout the study to monitor progress and adjust treatment if necessary. These visits include physical examinations and discussions about any side effects or concerns.
Step 5
Completion of study
The study duration varies between 24 to 52 weeks, depending on individual circumstances. Upon completion, participants undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

11 criteria

Age between 12 and 80 years, both males and females. Females must either not be able to have children or use a highly effective form of birth control.
Must have used an electronic diary (eDiary) correctly at least 70% of the time during the screening period. This means completing the diary for any 10 mornings and 10 evenings and confirming taking 2 puffs of the trial inhaler for any 10 mornings and 10 evenings in the last 14 days before starting the trial.
No respiratory infection or worsening of asthma that required extra treatment in the 4 weeks before starting the trial.
Must have a documented history of asthma diagnosed by a doctor for at least 1 year before the first visit.
Must be regularly using a stable daily asthma treatment that includes a combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) with medium-to-high doses of ICS for at least 4 weeks before the first visit.
Must have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-7) at specific visits before starting the trial.
Must have a specific lung function measurement called FEV1 that is below a certain percentage of the normal predicted value at specific visits before starting the trial. For those 18 years and older, it should be less than 80%, and for those 12 to under 18 years, it should be less than 90%.
Must show improvement in lung function after using albuterol, a medication that helps open the airways. For those 18 years and older, the improvement should be at least 12% and 200 mL. For those 12 to under 18 years, the improvement should be at least 12% either in the 12 months before the first visit or at specific visits.
Must be willing and able, according to the study doctor, to adjust current asthma treatment as required by the study protocol.
Must demonstrate the correct technique for using the inhaler device.
Must not have used any asthma medication other than the trial inhaler and albuterol as needed during the screening period, except for allowed medications and treatments for asthma worsening.

Who cannot join the trial?

1 criterion

Having severe and inadequately controlled asthma. This means asthma that is not well managed with current treatments.

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Verified sites

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

Verified
Athens Medical Center S.A.
Thessaloniki, Greece
Verified
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
Leipzig, Germany
Verified
Ippokratio General Hospital Of Thessaloniki
Thessaloniki, Greece

Trial locations

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Investigated drugs

Budesonide
is a medication used in this trial to help control asthma symptoms. It works by reducing inflammation in the airways, making it easier to breathe.
Glycopyrronium
is included in the trial as part of a combination therapy. It helps to relax and open the airways in the lungs, which can improve breathing in people with asthma.
Formoterol Fumarate
is another medication used in the trial. It is a long-acting bronchodilator that helps to keep the airways open, making it easier for asthma patients to breathe.
Symbicort
is a combination inhaler that contains both Budesonide and Formoterol Fumarate. It is used in the trial to compare its effectiveness with other treatments in improving lung function and reducing asthma exacerbations.

What is already known about the treatment

Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) – This medication is administered via inhalation using a metered dose inhaler. It is currently being studied in clinical trials for its effectiveness in treating severe and inadequately controlled asthma. The main therapeutic indication is to improve lung function and reduce asthma exacerbations. At the molecular level, Budesonide is a corticosteroid that reduces inflammation, Glycopyrronium is a long-acting muscarinic antagonist that helps open airways, and Formoterol Fumarate is a long-acting beta-agonist that relaxes muscles in the airways to improve breathing. This combination is classified pharmacologically as a combination inhaler for asthma management.

Investigated diseases

Severe and inadequately controlled asthma – This is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. Individuals with this form of asthma experience frequent and severe symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The condition is considered inadequately controlled when these symptoms persist despite the use of standard asthma medications. Over time, the inflammation can cause the airways to become more sensitive and reactive to various triggers, such as allergens, exercise, or cold air. This can result in asthma exacerbations, which are episodes of worsening symptoms that may require additional medical attention. The progression of the disease can vary, with some individuals experiencing more frequent or severe exacerbations than others.