Not recruiting

Study on the Effectiveness and Safety of Budesonide and Formoterol Fumarate for Patients with Poorly Controlled 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 effectiveness and safety of treatments for people with asthma that is not well controlled. The study will compare different inhalation treatments, including a combination of budesonide and formoterol fumarate in a metered dose inhaler, known as BFF (PT009), and another inhaler called BD (PT008), which contains only budesonide. Additionally, the study will involve the use of an open-label inhaler called Symbicort, which also contains budesonide and formoterol fumarate. A placebo will be used for training purposes only.

The purpose of the study is to assess how well these treatments improve lung function in participants with inadequately controlled asthma. Participants will use the inhalers over a period of 24 weeks. The study will monitor changes in lung function, specifically looking at the forced expiratory volume (FEV1), which measures how much air a person can exhale in one second. The study will also track the number of puffs of rescue medication used by participants and assess their response to treatment using questionnaires about asthma control and quality of life.

Throughout the study, participants will be asked to use the inhalers as directed and attend regular check-ups to monitor their progress. The study aims to provide valuable information on the effectiveness of these treatments in managing asthma symptoms and improving the quality of life for those affected by this condition.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, asthma history, and current treatment regimen.
Participants must demonstrate the ability to use a metered dose inhaler (MDI) correctly and maintain a certain level of compliance with an electronic diary (eDiary).
Step 2
Initial assessment
An initial assessment is conducted to evaluate lung function and asthma control. This includes measuring the forced expiratory volume (FEV1) before and after using a bronchodilator.
Participants must show a certain level of asthma stability and be willing to adjust their current asthma therapy as required.
Step 3
Randomization and treatment
Participants are randomly assigned to receive either the study medication or a comparator. The study medication is a combination of budesonide and formoterol fumarate delivered via a metered dose inhaler.
The dosage is 320 micrograms of budesonide and 9.6 micrograms of formoterol fumarate, administered twice daily through inhalation.
Step 4
Ongoing monitoring
Participants are monitored over a 24-week period to assess changes in lung function and asthma control.
Regular visits are scheduled to measure FEV1 and evaluate the use of rescue medication.
Step 5
Final assessment
At the end of the 24-week period, a final assessment is conducted to determine the overall effectiveness and safety of the treatment.
This includes evaluating changes in lung function and the number of puffs of rescue medication used.

Who can join the trial?

11 criteria

Participants must be between 12 to 80 years old, both males and females. Females must either not be able to have children or use a highly effective form of birth control.
Participants should be able to use the inhaler device correctly.
Participants must have used the electronic diary correctly at least 70% of the time during the screening period. This means they should have recorded taking 2 puffs of the inhaler in the morning and evening for at least 10 days in the last 14 days before starting the study.
Participants need to have a history of asthma diagnosed by a doctor for at least 6 months before the first visit. For those aged 12 to under 18, healthcare records for one year before the first visit must be provided.
Participants should have been using a stable daily asthma treatment with inhaled corticosteroids (ICS) or a combination of ICS and long-acting beta-agonists (LABA) for at least 8 weeks before the first visit.
Participants must have an Asthma Control Questionnaire (ACQ-7) score of 1.5 or higher at specific visits. This score helps measure how well asthma is being controlled.
Participants should have a lung function test result called FEV1 (Forced Expiratory Volume in 1 second) that is less than 90% of the predicted normal value at certain visits. At one visit before starting the study, the FEV1 should be between 50% to 90% of the predicted value.
Participants must show improvement in lung function after using albuterol, a medication that helps open the airways. For those 18 years and older, the FEV1 should increase by at least 12% and 200 mL. For those aged 12 to under 18, the FEV1 should increase by at least 12%.
Participants' lung function test results should not change by 20% or more between certain visits.
Participants should have stable asthma during the initial period of the study, as judged by the study doctor.
Participants must be willing and able, according to the study doctor, to adjust their current asthma treatment as required by the study protocol.

Who cannot join the trial?

1 criterion

Participants with **inadequately controlled asthma** cannot join the study. This means their asthma symptoms are not well managed with their current treatment.

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Verified sites

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

Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Verified
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
Leipzig, Germany
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

Trial locations

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Investigated drugs

Budesonide
is a medication used in this trial to help control asthma symptoms. It is a type of corticosteroid that works by reducing inflammation in the airways, making it easier to breathe.
Formoterol Fumarate
is another medication involved in the trial. It is a long-acting bronchodilator that helps to relax muscles in the airways, improving airflow and making breathing easier for people with asthma.
Symbicort® Turbuhaler®
is an open-label treatment used in the study. It combines budesonide and formoterol fumarate in a single inhaler. This combination helps to both reduce inflammation and relax airway muscles, providing comprehensive asthma control.

What is already known about the treatment

Budesonide
Budesonide is administered as a metered dose inhaler and is used to treat inadequately controlled asthma. It is a well-established medication in medical literature, known for its effectiveness in reducing inflammation in the airways. Budesonide works by binding to glucocorticoid receptors, which helps decrease the production of inflammatory substances in the body. It is classified as a corticosteroid, which is a type of anti-inflammatory medication.
Formoterol Fumarate
Formoterol Fumarate is also administered via a metered dose inhaler and is used in combination with other medications to manage inadequately controlled asthma. It is recognized in medical literature for its role in improving lung function by relaxing the muscles around the airways. Formoterol Fumarate acts as a long-acting beta-agonist, which helps to open the airways and make breathing easier. It is classified as a bronchodilator, which is a type of medication that helps to relieve symptoms of asthma.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. Symptoms often include wheezing, coughing, shortness of breath, and chest tightness. The severity and frequency of these symptoms can vary, and they may worsen during physical activity or at night. Asthma can be triggered by various factors such as allergens, respiratory infections, cold air, or stress. Over time, if not managed properly, asthma can lead to persistent airway inflammation and remodeling. Inadequately controlled asthma refers to a state where symptoms are not effectively managed, leading to frequent exacerbations and impaired lung function.