Study on the Effectiveness and Safety of Budesonide and Formoterol Fumarate for Patients with Poorly Controlled Asthma

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What is this study about?

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.

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).

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Lungenpraxis Witten	Witten	Germany
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Policum Berlin Studien GmbH	Berlin	Germany
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR	Berlin	Germany
Giromed Institute S.L.P.	Barcelona	Spain
Asst Di Mantova	Mantova	Italy
Salvus-Klinische Studien GmbH	Leipzig	Germany
Smo Md GmbH	Magdeburg	Germany
Medaimun GmbH	Frankfurt	Germany
Siteworks GmbH	Hanover	Germany
Klinische Forschung Berlin GbR	Berlin	Germany
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR	Leipzig	Germany
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Dsm Mqye Femb Bsiufwj Fzguvmza Fopn Itreko Mvixqfy Ull Pulaikplrxf	Leipzig	Germany
Pwxyig Dri Sjfim Wmheml	Berlin	Germany
Plphrcatxpnpdqa Sqzzaskrvwyilc Mys dtzcgfrjbdvpfjm	Berlin	Germany
Hthxveoy Upqjltnggaocd Hujdkrck Txrib y Pstebo Itrdaatt Cpdevg dwjgtgumdggoqynce (bwxr	Badalona	Spain
Afwlpktor Mpq Bobthi Gdyc	Landsberg Am Lech	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	10.05.2022
Italy	Not recruiting	10.05.2022
Spain	Not recruiting	10.05.2022

Trial locations

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.

Investigated diseases:

Asthma

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.

Trial ID:

2024-513568-24-00

Protocol code:

D5982C00006

NCT ID:

NCT05202262

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Budesonide and Formoterol Fumarate for Patients with Poorly Controlled Asthma

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