Study on the Effectiveness and Safety of AZD4604 for Adults with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

2 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for asthma, specifically in adults who have moderate to severe asthma that is not well controlled with their current medication. The treatment being tested is called AZD4604, which is administered as an inhalation powder. The study aims to evaluate how effective and safe AZD4604 is when taken twice daily over a period of twelve weeks.

Participants in the study will be randomly assigned to receive either AZD4604 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The main goal is to see if AZD4604 can improve asthma symptoms and reduce the frequency of asthma attacks compared to the placebo.

Throughout the study, participants will have regular check-ups to monitor their asthma symptoms and overall health. The study will track changes in lung function and asthma control over the twelve-week period. By the end of the study, researchers hope to gather valuable information about the potential benefits of AZD4604 for people with moderate to severe asthma.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, asthma severity, and treatment history.

Participants must be between 18 and 80 years old and have a documented history of moderate-to-severe asthma that is not well controlled with current medication.

2 run-in period

During this period, participants continue their usual asthma medication to ensure stability before starting the trial treatment.

Compliance with medication and study requirements is monitored through electronic assessments.

3 randomization and treatment

Participants are randomly assigned to receive either the study medication, AZD4604, or a placebo.

The medication is administered as an inhalation powder, taken twice daily for a duration of twelve weeks.

4 treatment monitoring

Throughout the twelve-week treatment period, participants’ lung function and asthma symptoms are regularly assessed.

Key assessments include lung function tests and symptom questionnaires at weeks 4 and 12.

5 end of treatment

At the end of the treatment period, final assessments are conducted to evaluate the efficacy and safety of the medication.

Participants’ experiences and any changes in asthma symptoms are documented.

Who Can Join the Study?

Must be between 18 to 80 years old at the time of signing the consent form.
Both males and females can participate. Females should use birth control methods as per local rules. No restrictions for males or their female partners.
Must have a lung function test result called FEV1 (Forced Expiratory Volume in 1 second) between 40% and 90% of what is predicted for a healthy person.
FEV1 should not change by 20% or more between the first and third visits.
Must have an ACQ-6 score (Asthma Control Questionnaire) of 1.5 or higher.
Must take at least 80% of their usual asthma medication during the initial study period.
Must complete at least 80% of daily electronic health assessments during the initial study period and 14 days before the third visit.
Females of childbearing potential or on hormone replacement therapy must have a negative pregnancy test before starting the study medication.
Must have been treated with high-dose ICS (Inhaled Corticosteroids) and LABA (Long-Acting Beta-Agonists) at a stable dose for at least 3 months before the first visit.
Must have had at least one severe asthma attack in the year before the first visit.
Must be able to perform lung function tests according to specific guidelines.
Must have a documented history of asthma in the 10 years leading up to the first visit, with a clinical diagnosis at least 12 months before the first visit.
Must be able and willing to follow the study requirements, including reading, writing, understanding the language used in the study, and using electronic devices like a spirometer.
Must weigh at least 40 kg and have a body mass index (BMI) of less than 35 kg/m².

Who Cannot Join the Study?

Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent asthma attack that required hospitalization.
Patients who are currently using other medications that might affect the study results.
Patients who have a history of not following medical advice or treatment plans.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of drug or alcohol abuse.
Patients who have a condition called COPD (Chronic Obstructive Pulmonary Disease), which affects breathing.
Patients who have a history of cancer, unless it was a type that is not expected to come back.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut für Allergie- und Asthmaforschung Berlin	Berlin	Germany
Bispebjerg Hospital	Copenhagen	Denmark
Individual Practice For Specialized Medical Care Dr. Nikolay Kostadinov EOOD	Burgas	Bulgaria
Clinical Studies Pankow	Berlin	Germany

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Region Stockholm – SLSO	Stockholm	Sweden
Pneumo Studien Darmstadt GmbH	Darmstadt	Germany
MECS Research GmbH	Berlin	Germany
MECS Medical and Clinical Studies Cottbus GmbH	Cottbus	Germany
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Medaimun GmbH	Frankfurt	Germany
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Aalborg University Hospital	Aalborg	Denmark
Hopital Prive D Antony	Antony	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Rigshospitalet	Copenhagen	Denmark
Region Vaesterbotten	Umea	Sweden
Servei De Salut De Les Illes Balears	Palma	Spain
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Hospital Costa del Sol	Marbella	Spain
Htrercik Hokbplnd	Hvidovre	Denmark
Axmgvm Axjffqlds Eggr	Varna	Bulgaria
Sewifhbjzavaiw Bufvuex Zg Abhfubr Lcsgoauo Nc Ppatdevxvhqyyteqlkxt Zzzzzyzozwpc Dx Nqniti Phggazvofsemdqjlax Euub	Pazardzhik	Bulgaria
Gzgtmye Peldvpazggylb Rjdnluvt Iujjjrhwc Baio	Groningen	The Netherlands
Cvl dabsvpgifroajk	Epagny Metz Tessy	France
Schtxwayaabbrc Dcf mkyi Srokecwgu	Peine	Germany
Gbcynukdyxruljrciom fxw Kzqfalqeotu ued Ppgtsxsoqek	Berlin	Germany
Avjcuw Uzndsogwwn Hjsgxkep	Aarhus	Denmark
Kmpvhydr dqh Uddgbjzvjrda Mrwrmhgq Ass	Munich	Germany
Kvup Gttn	Bendorf	Germany
Cdh Clysk Rvmctviwxur	Lyon	France
Hmaujvsq Vkxu dmgnabfq	Barcelona	Spain
Hhpskhtm Ugscumuihxjiwe Saugcydrsl &yqmlqc Hsjhwjw dw Homhmuotqiu	STRASBOURG, Alsace	France
Myzzcyc Cqtjsi Ijham Eicc	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	06.11.2023
Denmark	Not recruiting	06.11.2023
France	Not recruiting	06.11.2023
Germany	Not recruiting	06.11.2023
Spain	Not recruiting	06.11.2023
Sweden	Not recruiting	06.11.2023
The Netherlands	Not recruiting	06.11.2023

Trial locations

Investigated drugs:

(2R)-N-[3-(5-Fluoro-2-{[2-Fluoro-3-(Methylsulfonyl)Phenyl]Amino}-4-Pyrimidinyl)-1H-Indol-7-Yl]-3-Methoxy-2-(4-Methyl-1-Piperazinyl)Propanamide-1-Hydroxy-2-Naphthoic Acid

AZD4604 is an investigational medication being studied for its potential to help adults with moderate to severe asthma that is not well controlled with their current treatment. This medication is taken twice daily and is being evaluated for its effectiveness and safety over a period of twelve weeks. The goal of the study is to see if AZD4604 can improve asthma symptoms and overall lung function in patients who are already using medium to high doses of inhaled corticosteroids and long-acting beta-agonists.

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 severity of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. In moderate-to-severe cases, asthma may not be well-controlled even with the use of medium to high doses of inhaled corticosteroids and long-acting beta-agonists. This can result in frequent exacerbations, where symptoms worsen significantly and may require additional medical attention. The progression of asthma involves periods of symptom flare-ups and remissions, influenced by various triggers such as allergens, exercise, and respiratory infections.

Trial ID:

2023-506000-50-00

Protocol code:

D8210C00003

NCT ID:

NCT06020014

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effectiveness and Safety of AZD4604 for Adults with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?