Study on the Safety and Effectiveness of AZD8630 for Adults with Uncontrolled Asthma at Risk of Exacerbations

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for adults with uncontrolled asthma. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The study will test a medication called AZD8630, which is an inhalation powder designed to help manage asthma symptoms. Participants in the trial will receive either AZD8630 or a placebo, which is a substance with no active medication, to compare the effectiveness of the treatment.

The purpose of the study is to evaluate how well AZD8630 works in preventing asthma flare-ups, known as exacerbations, in people whose asthma is not well controlled despite using other medications. The trial will last for 12 weeks, during which participants will take the medication once daily. The study will also assess the safety of AZD8630 and its impact on lung function, asthma symptoms, and overall quality of life.

Participants will use a device called the Saphira to inhale the medication. This device is designed to deliver the dry powder form of AZD8630 directly to the lungs. The study aims to provide valuable information on the potential benefits of AZD8630 for people with asthma who are at risk of experiencing severe symptoms. The trial will help determine if AZD8630 can be a safe and effective option for managing asthma in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, AZD8630, or a placebo. This process is double-blind, meaning neither you nor the study team will know which one you are receiving.

2 medication administration

You will take the assigned medication as an inhalation powder once daily. The duration of this treatment is 12 weeks.

3 regular assessments

Throughout the study, you will have regular assessments to monitor your asthma symptoms and overall health. These assessments will include lung function tests and questionnaires about your asthma control and quality of life.

4 home monitoring

You will be required to perform daily assessments at home, including measuring your peak expiratory flow (PEF) in the morning and evening. This helps track your lung function over time.

5 clinic visits

You will have scheduled visits to the clinic at specific intervals during the study. These visits will include more detailed lung function tests and other evaluations to ensure your safety and the effectiveness of the treatment.

6 end of study

At the end of the 12-week period, you will have a final assessment to evaluate the overall impact of the treatment on your asthma. This will include a review of your symptoms, lung function, and any side effects experienced during the study.

Who Can Join the Study?

Patient must be between 18 and 80 years old at the time of signing the consent form.
Patient must have a lung function test result called FEV1 (Forced Expiratory Volume in 1 second) that is at least 40% of the expected value at both the first and second visits.
The increase in FEV1 between the first and second visits should be less than 400 ml.
Patient must have a history of asthma worsening (called exacerbations) in the last 12 months, with specific criteria for severity and frequency.
Patient must have at least 80% compliance with their usual asthma medication during the initial period of the study.
Patient must complete daily assessments, including electronic diaries and peak flow measurements, at least 80% of the time during the 14 days before the second visit.
If the patient is on high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) and is eligible for injectable biologic therapy, they must be unable or unwilling to receive it, or it must be deemed inappropriate by the investigator.
Patient’s BMI (Body Mass Index) must be between 18 and 37 kg/m² at the time of signing the consent form and at the second visit.
Female patients of childbearing potential must have negative pregnancy tests at the first and second visits and must not be breastfeeding. They must also agree to use effective birth control methods during the study and for 20 days after the last dose of the study medication.
Male patients and their female partners of childbearing potential must agree to use effective birth control methods and refrain from donating sperm or fathering a child during the study and for 20 days after the last dose of the study medication.
Patient must be able to give signed informed consent.
Patient must have a documented diagnosis of asthma for at least 12 months, with specific criteria for confirmation.
Patient must be treated with medium- or high-dose ICS in combination with LABA, with a stable dose for at least 30 days before the first visit. Additional asthma medications at a stable dose are allowed.
Patient must have uncontrolled asthma, demonstrated by an ACQ-6 (Asthma Control Questionnaire) score of 1.5 or higher at both the first and second visits.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the study medications.
Patients who are currently participating in another clinical trial.
Patients who have a significant medical condition other than asthma that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse within the past year.
Patients who have had a major surgery within the past three months.
Patients who have been diagnosed with a serious mental health condition that is not well controlled.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR	Marburg	Germany
Pneumocare	Namur	Belgium
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR	Berlin	Germany
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Plicni Stredisko Teplice s.r.o.	Teplice	Czechia
Salvus-Klinische Studien GmbH	Leipzig	Germany
Fakultni Nemocnice Plzen	Plzen	Czechia
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Odense University Hospital	Odense	Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Meander Medical Center	Amersfoort	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Hospital Vithas Xanit Internacional	Benalmadena	Spain
Hopital Beaujon	Clichy	France
Servei De Salut De Les Illes Balears	Palma	Spain
Roskilde University	Roskilde	Denmark
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Zapa Jj s.r.o.	Levice	Slovakia
Mveytwjs	Mechelen	Belgium
Pscfvakcyiw Vydmntswd scugie	Varnsdorf	Czechia
Cimchz Hhahilbnhrv Unnfitsomfkrd Rkgbc	Reims	France
Hhkepkom Havcbhsm	Hvidovre	Denmark
Hrcijpjz Uyenxcutyeevv Mocbncj Di Vmhoexxdki	Santander	Spain
Eyrrzyj	Mechelen	Belgium
Adeohc soiqnt	Kosice	Slovakia
Aeanuvvdbyp chimpbm seiuoj	Kezmarok	Slovakia
Pcnod slvlfk	Presov	Slovakia
Epla sjaclu	Zilina	Slovakia
Aqr Jv sxumvn	Topolcany	Slovakia
Pkcqvg cnpnaow sajbnm	Prague	Czechia
Hdwnhc Hnozcsfb	Herlev	Denmark
Awuehrhugc Pxbggpgf Hhgehjbp Dv Mntrzcnna	Marseille	France
Aoqtqz Uqckpsnzxt Hwllejgf	Aarhus	Denmark
Uxnmajubcf Dhrps Scnca Dl Rzwr Lk Sydekafl	Rome	Italy
Pjfmzy acjdorxln Kaxbzas sqqglt	Kralupy nad Vltavou	Czechia
Cqy Clgob Rkhoctsyecn	Lyon	France
Hkxouatv Vqaa dybfemsz	Barcelona	Spain
Lkbes subdev	Topolcany	Slovakia
Alihtocmw Mvv Bfewyc Gyul	Landsberg Am Lech	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	23.01.2025
Czechia	Not recruiting	23.01.2025
Denmark	Not recruiting	23.01.2025
France	Not recruiting	23.01.2025
Germany	Not recruiting	23.01.2025
Italy	Not recruiting	23.01.2025
Slovakia	Not recruiting	23.01.2025
Spain	Not recruiting	23.01.2025
The Netherlands	Not recruiting	23.01.2025

Trial locations

Investigated drugs:

AZD8630 is a medication being tested to help people with asthma. Asthma is a condition where the airways in the lungs become narrow and make it hard to breathe. This medication is inhaled, which means you breathe it in through your mouth so it can go directly to your lungs. The goal of using AZD8630 is to see if it can help prevent asthma attacks, which are times when asthma symptoms suddenly get worse. The study is looking at how well AZD8630 works and if it is safe for people to use over a period of 12 weeks.

Investigated diseases:

Asthma

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The disease progresses with episodes known as asthma attacks, where symptoms become more severe and can be triggered by allergens, exercise, cold air, or stress. Over time, if not managed, asthma can lead to persistent airway inflammation and remodeling, which may cause a decline in lung function. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more frequent and severe exacerbations. Asthma is often managed by avoiding triggers and using medications to control inflammation and open the airways.

Trial ID:

2024-514228-18-00

Protocol code:

D6830C00003

NCT ID:

NCT06529419

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of AZD8630 for Adults with Uncontrolled Asthma at Risk of Exacerbations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?