Study on the Effectiveness and Safety of Budesonide, Glycopyrronium, and Formoterol Inhaler for Adults and Adolescents with Severe Asthma Not Well Controlled
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 study will test a combination of medications delivered through an inhaler. The main treatment being tested is a combination of Budesonide, Glycopyrronium, and Formoterol Fumarate in a metered dose inhaler (MDI), referred to as BGF MDI. This will be compared to other treatments, including a combination of Budesonide and Formoterol Fumarate MDI, and a medication called Symbicort, which is also an inhaler containing Budesonide and Formoterol Fumarate Dihydrate.
The purpose of the study is to assess how well the BGF MDI works in improving lung function and reducing asthma attacks compared to the other treatments. Participants will be randomly assigned to receive either the BGF MDI, one of the other treatments, or a placebo. The study will last between 24 to 52 weeks, during which participants will use their assigned inhaler daily. The study will monitor changes in lung function and the frequency of asthma attacks to determine the effectiveness of the treatments.
Throughout the study, participants will be asked to visit the clinic regularly for check-ups and to provide information about their asthma symptoms. The study aims to provide valuable information on whether the new combination of medications can offer better control of severe asthma symptoms compared to existing treatments. This research could lead to improved treatment options for people with severe asthma who do not respond well to current therapies.
1joining the study
Upon joining the study, the participant will be 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.
2treatment administration
Participants will 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 via inhalation. The specific dosage and frequency will be determined by the study protocol and communicated to the participant at the start of the treatment phase.
3monitoring and assessments
Throughout the study, participants will undergo regular monitoring to assess lung function and the effect of the treatment on asthma symptoms.
Participants will be required to complete an electronic diary (eDiary) to record their daily symptoms and medication use. Compliance with the eDiary is important for accurate data collection.
4follow-up visits
Participants will attend scheduled follow-up visits at the study site. These visits will include assessments of lung function and overall health.
The frequency and number of follow-up visits will depend on the specific requirements of the study protocol.
5end of treatment
The treatment period will last between 24 to 52 weeks, depending on the study group and individual response to treatment.
At the end of the treatment period, participants will undergo final assessments to evaluate the overall effectiveness and safety of the treatment.
6study completion
Upon completion of the study, participants will receive information about the study results and any further steps, if applicable.
Participants may be asked to provide feedback on their experience during the study.
Who Can Join the Study?
Participants must be between 12 and 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 need to have a history of asthma diagnosed by a doctor for at least one year before the first visit.
Participants should be regularly using a stable daily treatment for asthma that includes a combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) with medium-to-high doses of ICS for at least four weeks before the first visit.
Participants must have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-7) at specific visits before starting the trial. This score helps measure how well asthma is being controlled.
Participants’ lung function, measured by a test called FEV1, should be below 80% of the predicted normal value for those 18 years and older, and below 90% for those aged 12 to under 18, at specific visits before starting the trial.
Participants must show an improvement in lung function after using a medication called albuterol. For those 18 years and older, the improvement should be at least 12% and 200 mL. For those aged 12 to under 18, the improvement should be at least 12% either in the 12 months before the first visit or at specific visits.
Participants should be willing and able, according to the study doctor, to adjust their current asthma treatment as required by the study.
Participants must demonstrate an acceptable technique for using a metered-dose inhaler (MDI), which is a device used to deliver asthma medication.
Participants should not have had any respiratory infections or asthma flare-ups treated with systemic corticosteroids or additional ICS treatment in the four weeks before starting the trial.
Participants must have used the 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 the use of the run-in medication for any 10 mornings and 10 evenings in the last 14 days before starting the trial.
Participants should not have used any asthma medication other than the run-in medication and albuterol as needed during the screening period, except for allowed medications and treatments for asthma flare-ups.
Who Cannot Join the Study?
Having a type of asthma that is very severe and not well controlled.
Being outside the age range specified for the study.
Having any other medical condition that might interfere with the study.
Being pregnant or planning to become pregnant during the study.
Having a history of smoking or using tobacco products.
Using certain medications that might affect the study results.
Having participated in another clinical trial recently.
Having a known allergy to any of the study medications.
Being unable to follow the study procedures or instructions.
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. This medication is often used as a long-term treatment to prevent asthma attacks.
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. This medication is typically used to provide relief from asthma symptoms.
Formoterol Fumarate is another medication used in the trial. It is a long-acting bronchodilator that helps to relax muscles in the airways, improving airflow and making it easier to breathe. It is often used in combination with other medications to manage asthma symptoms.
Symbicort is a combination inhaler that contains both Budesonide and Formoterol Fumarate. It is used in the trial to compare its effectiveness with other treatment options. Symbicort helps to control and prevent asthma symptoms by reducing inflammation and opening the airways.
Severe and Inadequately Controlled Asthma – This form of asthma is characterized by persistent symptoms and frequent exacerbations despite high-dose treatment. Individuals with this condition often experience difficulty in breathing, wheezing, and coughing, which can significantly impact daily activities. The disease progresses with episodes of worsening symptoms, known as exacerbations, which can be triggered by various factors such as allergens, infections, or stress. These exacerbations can lead to a decline in lung function over time. Management of this condition typically involves a combination of medications to control symptoms and prevent exacerbations. Regular monitoring and adjustments in treatment are often necessary to manage the disease effectively.
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