AZD4604 for Asthma
(AJAX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called AZD4604 for individuals with moderate-to-severe asthma. Researchers seek to determine if this medication, taken twice daily with a dry-powder inhaler, can manage asthma symptoms more effectively than a placebo (a substance with no active medication). The trial seeks participants who have struggled with asthma control despite using a combination of inhaled corticosteroids and long-acting beta-agonists for at least a month and have experienced a severe asthma attack in the past year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in asthma care.
Will I have to stop taking my current medications?
The trial requires participants to continue their current asthma medications, specifically medium-high dose inhaled corticosteroids (ICS) with long-acting beta-agonists (LABA), at a stable dose for at least 28 days before starting the trial. However, certain medications like systemic corticosteroids and some biologics must be stopped before the trial.
Is there any evidence suggesting that AZD4604 is likely to be safe for humans?
Research has shown that AZD4604 has been tested in people with mild asthma. In these studies, participants generally tolerated the treatment well, with most not experiencing major side effects. The treatment also presented few new side effects, which are issues that can occur with new medications.
While researchers continue to collect detailed safety information, early results are encouraging. These findings suggest that AZD4604 could be a safe option for people with asthma, although further research is needed to confirm this.12345Why do researchers think this study treatment might be promising for asthma?
Unlike the standard asthma treatments that often focus on relieving symptoms with inhaled corticosteroids or bronchodilators, AZD4604 is unique because it targets the underlying inflammation in the airways. This new approach aims to directly modulate the immune response, potentially offering more effective and long-lasting control over asthma symptoms. Researchers are excited about AZD4604 because it represents a shift towards treating the root cause of asthma rather than just managing its symptoms, which could lead to improved quality of life for patients.
What evidence suggests that AZD4604 might be an effective treatment for asthma?
Research shows that AZD4604, an inhaled treatment, could be promising for asthma. In earlier studies, patients experienced about a 50% reduction in a marker of airway inflammation called FeNO, compared to a placebo, after just three days of treatment. This trial will compare AZD4604 with a placebo to further evaluate its potential to reduce lung inflammation. It may also improve overall asthma control and lung function. These findings suggest that AZD4604 could effectively manage asthma symptoms.23678
Are You a Good Fit for This Trial?
Adults aged 18-80 with moderate-to-severe asthma uncontrolled by current meds, who've had a severe asthma attack in the last year. They must have used their inhaler correctly during a run-in period and meet lung function criteria. Smokers or those with certain health conditions like recent serious infections or cancer are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD4604 or placebo twice daily using a dry-powder inhaler over a 12-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD4604
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology