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

3 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Pneumologisches Forschungsinstitut Hohegeest GbR Geesthacht Germany
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
Lungenpraxis Witten Witten Germany
PPX Pneumologische Praxis Xanthopoulos Fürstenwalde Germany
Clinical Studies Pankow Berlin Germany
Pneumologicum Hanover Germany
Institut für klinische Forschung Pneumologie Frankfurt Germany
Research Center for Medical Studies (RCMS) Berlin Germany

Other Sites

Site Name City Country Status
University General Hospital Of Ioannina Ioannina Greece
General University Hospital Of Patras Patras Greece
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Leipzig Germany
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Athens Naval Hospital Athens Greece
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Medaimun GmbH Frankfurt Germany
MediTrial s.r.o. Jindřichův Hradec Czechia
D A W O N spol. s r.o. Prague Czechia
Zapa Jj s.r.o. Levice Slovakia
Danimed spol. s r.o. Levice Slovakia
MUDr. I. Cierna Peterova s.r.o. Brandys Nad Labem Czechia
Siteworks GmbH Hanover Germany
Klinische Forschung Berlin GbR Berlin Germany
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Hospital Cuf Descobertas S.A. Lisbon Portugal
Alian s.r.o. Bardejov Slovakia
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Pneumo Studien Darmstadt GmbH Darmstadt Germany
Plicni Stredisko Teplice s.r.o. Teplice Czechia
Salvus-Klinische Studien GmbH Leipzig Germany
424 Military General Training Hospital Thessaloniki Greece
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Berlin Germany
General Hospital Of Corfu Agia Eirini Corfu Greece
MECS Research GmbH Berlin Germany
Velocity Clinical Research Germany GmbH Standort Berlin Berlin Germany
Loskv Gckqiti Hvukaraq Oq Aavsjt Athens Greece
Agegjn sumohc Kosice Slovakia
Akmjor Mydsuvs Codwou Ssgz Thessaloniki Greece
Uyxjicnzab Gpkwlux Hgfknmne Ardpyre Athens Greece
Uodxazwl Vphvumxb Njbvpzkcd Suo Rrjdghdcwm Fwgdvceb Nsszwhkjb Ruzomberok Slovakia
Oxlgjjns nsiwxrvpr Mjzgt Birdmkab aqyc nxlfiimxy Seqqdromquamq kyozi Mlada Boleslav Czechia
Puubps Dba Jwrp Wkhoywz Pluloqyytharfig Safjmiwldxrmwu Leipzig Germany
Amj Jv szobhu Topolcany Slovakia
Psibgg aqvfyiszhh sgvybq Poprad Slovakia
Pmewc skigmb Presov Slovakia
Agyfxibczw kpqhpqzuw igkgiavlvb a axdujlfqyep Mekyh Itmtu Hswksoswt Šurany Slovakia
Ahnryvypcgc ckeyyox skylec Kezmarok Slovakia
Pcfvxtzeuka Vamhcanjf snqatr Varnsdorf Czechia
Mudipp smwnkm Nove Zamky Slovakia
Ehng sccbtr Zilina Slovakia
Secrhjh stbgob Kosice Slovakia
Pmzhey ahrylqnhr Roclscqv Rokycany Czechia
Ggzvgcdmtxhswirrxyk fjc Koquvmpabab uve Plkugasqgwo Berlin Germany
Kzuw Genj Bendorf Germany
Sgfkicorrofzlp Dcx Kcqmjr Frankfurt Germany
Cemiozwny suzcwk Lovosice Czechia
Auxejtgxl Mjp Bzeqqo Gtmr Landsberg Am Lech Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
01.03.2021
Germany Germany
Not recruiting
01.03.2021
Greece Greece
Not recruiting
01.03.2021
Portugal Portugal
Not recruiting
01.03.2021
Slovakia Slovakia
Not recruiting
01.03.2021

Trial locations

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.

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.

Trial ID:
2023-505786-88-00
Protocol code:
D5982C00008
NCT ID:
NCT04609904
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Efficacy and Safety of Inhaled Glycopyrronium Bromide Added to Budesonide and Formoterol Fumarate in Children 4‑12 Years with Asthma (Placebo‑Controlled)

    Recruiting

    2 1
    Investigated Diseases:
    Czechia Hungary Poland
  • GB-0895 for Severe Uncontrolled Asthma in Adults and Adolescents

    Recruiting

    3 1
    Bulgaria Croatia Czechia Germany Greece Hungary +4