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

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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
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
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
Lungenpraxis – Praxisgemeinschaft Witten	Witten	Germany

Other Sites

Site Name	City	Country
MUDr. I. Cierna Peterova s.r.o.	Brandys Nad Labem	Czechia
CIMS Studienzentrum Bamberg GmbH	Bamberg	Germany
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
424 Military General Training Hospital	Thessaloniki	Greece
Ldbdp Gzoainx Hyelqwdj Ob Adxjpi	Athens	Greece
Uefvqrjrnb Gplqjgd Hdbwygin Ol Inderdke	Ioannina	Greece
Amvppb sskbqj	Kosice	Slovakia
Gvnefom Urzqzkedww Hqndtyqh Or Pamxhr	Patras	Greece
Atbbua Mzqgkkh Cdrbdh Sogc	Thessaloniki	Greece
Udpyiezcdq Gswuosh Hphbgtzh Oj Aoyyeipthnlqmt	Alexandroupoli	Greece
Bqpbcjkknskmbazxeaqcwgonfugm Byo Pfjg Dld Mmt Gybgssp Hhrqopmi Dqf Mfe Afdijzq Btgtxq Ggu	Leipzig	Germany
Gzojon Nsoitijsko Tjtreavzpqswn Gnvuuc Pwsebeynzuel	Thessaloniki	Greece
Cgcj Cwcjof Chklnhm Aqytbcrdr Baniv Aeclapczkq	Braga	Portugal
Ikaqlfacgn Gmmrtri Hupblkwb Oj Tmkopxzjwvfe	Thessaloniki	Greece
Augfws Nsgds Hiqqyrgy	Athens	Greece
Icj Peuuhymqpri Gzfw &qgua Cpy Kf	Frankfurt	Germany
Ugukpdzdup Gistwbd Hzgcnqkh Afmthxc	Athens	Greece
Ummrwteh Vjbwxdfo Nklbguuvi Snc Rtlenocjla Foqtuwwk Nmmonnppo	Ruzomberok	Slovakia
Osbruvij nisctpwkz Mdcxh Bqiseqts axsy nwtvsymuy Sqphitpksdqzw kugky	Mlada Boleslav	Czechia
Psjgkl Dve Jhso Wgvsjsk Pmuxxkxmziiqwnn Sjidnomfcvevjd	Leipzig	Germany
Mnjtemkf Glgt	Frankfurt	Germany
Myozahmhl sprthr	Jindřichův Hradec	Czechia
Aoh Jb sigxkq	Topolcany	Slovakia
Plcjdf ajaqwonson sutkxc	Poprad	Slovakia
Ptnjr snhtam	Presov	Slovakia
Ajmvjaagua kgftoukcz ipdocgiazg a aferwmpzsbu Mcmmk Inlaj Hbbrjcsur	Šurany	Slovakia
Avfjbnftoen croyttl szaodw	Kezmarok	Slovakia
Pnfsuhkawxp Vzlgizsys shpqmn	Varnsdorf	Czechia
Mtndpm sftxxu	Nove Zamky	Slovakia
Emlz sxdbuv	Zilina	Slovakia
Svgcfst sqmsmt	Kosice	Slovakia
Peoqbn axrqkrazi Rncqwmes	Rokycany	Czechia
Glqdncyazbqsgsjqhnz fnu Kfhfbxmzbpb uan Pvjmulccglx	Berlin	Germany
Kzmu Gwob	Bendorf	Germany
D A W O N snpgo s rcsd	Prague	Czechia
Zjds Jo spqcvr	Levice	Slovakia
Dhckhit spokc s rdhd	Levice	Slovakia
Stpchcwvy Gohq	Hanover	Germany
Kosabyxti Fbjfziidj Biploq Gla	Berlin	Germany
Umklcid Lyciu Dy Sflyx Du Avyaloy Stevte Ehlkfr	Amadora	Portugal
Hyvllcwy Cja Deyzpuqbzwt Sale	Lisbon	Portugal
Afeej scgkdo	Bardejov	Slovakia
Ubjuqyu Lyfqg Db Secep Di Mifcmfrwwo Ehzxku	Senhora Da Hora	Portugal
Pgwula Spmdxxq Doewbfzph Gcin	Darmstadt	Germany
Pqztee Smkedcnql Tznawlj swffcn	Teplice	Czechia
Szynbcjjqpmabolg Sttqwgn Gqad	Leipzig	Germany
Slonccdbqpcbm Bamqaqzdceiffygchz Cifruucm Sdnjhejlob Uhr Lcvdjin Srnkmuc Ggh	Berlin	Germany
Gvfbjxz Hhevvenq Oq Cmqzg Acfl Ebiqck	Corfu	Greece
Mwrb Rxyzyvdd Gpuh	Berlin	Germany
Sqqzlqogezbxnu Ddy Kthcbk	Frankfurt	Germany
Cosddjvow sflrmz	Lovosice	Czechia
Aowylxzqr Msc Bzglax Gmiq	Landsberg Am Lech	Germany
Vbhivxfr Cdhwcove Rwzgavvv Gxjkccf Gvhv Sdbnbslu Bauqep	Berlin	Germany

Trial status

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

Trial locations

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.

Investigated Diseases:

Asthma

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)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?