What side effects are associated with this type of intervention?

Common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta agonists (LABA), leukotriene modifiers, and biologics. ICS can cause side effects such as oral thrush, hoarseness, and, in high doses, systemic effects like adrenal suppression. LABAs may lead to tremors, palpitations, and muscle cramps. Leukotriene modifiers can cause headaches, gastrointestinal disturbances, and, rarely, neuropsychiatric events. Biologics, such as mepolizumab and dupilumab, may cause injection site reactions, headaches, and increased risk of infections. Newer treatments like AZD4604 are still under investigation, but potential side effects would likely align with those of similar asthma medications.

What prior FDA approvals exist?

The FDA has approved several advanced treatments for severe asthma, particularly for patients who do not respond adequately to standard therapies like inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). Notable approvals include biologics such as mepolizumab, reslizumab, benralizumab, and dupilumab, which target specific pathways involved in the inflammatory process of asthma. These biologics are typically used for severe eosinophilic asthma and work by inhibiting interleukins or their receptors to reduce inflammation. Additionally, tiotropium, a long-acting muscarinic antagonist (LAMA), has been approved as an add-on therapy for asthma. These treatments represent significant advancements in managing severe asthma, offering options for patients with difficult-to-control symptoms.

What other types of research exist?

Promising alternatives to AZD4604 for asthma treatment include AZD5423, a nonsteroidal glucocorticoid receptor agonist, and AZD7594, a non-steroidal selective glucocorticoid receptor modulator. Both have demonstrated efficacy and safety in clinical trials for asthma patients.

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Monoclonal Antibodies

AZD4604 for Asthma (AJAX Trial)

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For female participants, a negative urine pregnancy test prior to administration of IMP

Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 3 months prior to Visit 1

Must not have

Any clinically significant cardiac or cerebrovascular disease

Evidence of active TB, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial tests a new asthma medication called AZD4604, which is inhaled regularly using a dry-powder inhaler. It targets adults whose moderate-to-severe asthma is not well-controlled by current treatments. The medication likely works by opening up the airways and reducing inflammation, making it easier to breathe.

Who is the study for?

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.

What is being tested?

The trial is testing AZD4604, an experimental drug for asthma delivered via inhaler twice daily against a placebo over 12 weeks. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo to ensure unbiased results.

What are the potential side effects?

While specific side effects of AZD4604 aren't listed here, common side effects for new asthma treatments can include throat irritation, headache, respiratory infections, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman and my pregnancy test before starting the treatment was negative.

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I have been on a stable dose of medium-high ICS and LABA for at least 3 months.

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My lung function test shows I'm between 40% and 90% of the expected value.

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I have been diagnosed with asthma in the last 10 years.

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I am between 18 and 80 years old.

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I weigh at least 40 kg and my BMI is less than 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major heart or brain blood vessel problems.

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I have TB that is either untreated or not fully treated.

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I have had cancer before, but it wasn't just a minor skin cancer.

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I haven't taken any biologic drugs for 6 months or 5 half-lives, whichever is longer.

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I am currently smoking or have smoked 10 or more pack-years.

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A family member of mine has had lung cancer.

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I have a significant lung condition that is not asthma.

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I am currently pregnant or breastfeeding.

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I have not had recent hepatitis, unexplained jaundice, or HIV.

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I have had blood clots in my veins before.

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I haven't used inhaled steroids or fast-acting asthma relievers for 15 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to first CompEx Asthma event

Secondary study objectives

ACQ-6

Average morning and average evening PEF

CAAT

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1Experimental Treatment1 Intervention

AZD4604

Group II: Arm 2Placebo Group1 Intervention

Placebo

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common asthma treatments include inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA). ICS work by reducing inflammation in the airways, LABAs relax the smooth muscles around the airways to improve airflow, and LAMAs block muscarinic receptors to prevent bronchoconstriction. These mechanisms are essential for asthma patients as they help control symptoms, reduce exacerbations, and improve lung function.