AZD8630 for Asthma

(APkITA Trial)

No longer recruiting at 16 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: Asthma medication

Must not be taking: Oral immunotherapy

Disqualifiers: Chronic respiratory disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new asthma treatment called AZD8630, an experimental inhaled medication, to evaluate its processing in the body, safety, and effectiveness when inhaled. It targets teens with asthma who regularly use asthma medication. Participants should not have experienced a severe asthma attack or respiratory infection recently. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current asthma medications. However, since daily use of asthma medication is required, you will likely continue your current treatment.

Is there any evidence suggesting that AZD8630 is likely to be safe for humans?

Research has shown that AZD8630 has been tested in people before. One study with healthy adults found AZD8630 to be safe, as most participants did not experience serious side effects. Another study involving people with asthma reported similar results. The treatment was generally well-tolerated, with no major issues after use.

Although specific numbers on side effects are not provided here, the progression of AZD8630 beyond initial testing stages suggests it is considered safe enough for further research. For those with asthma considering joining the study, early research indicates promising safety results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for asthma involve inhaled corticosteroids and bronchodilators that work by reducing inflammation and relaxing airway muscles. But AZD8630 is unique because it's delivered as a single inhaled dose using a dry powder inhaler, which could improve ease of use and adherence for patients. Researchers are excited about AZD8630 because it offers a potentially new approach to asthma management, possibly targeting underlying mechanisms differently than current medications. This could lead to more effective control of asthma symptoms with potentially fewer doses.

What evidence suggests that AZD8630 might be an effective treatment for asthma?

Research has shown that AZD8630, which participants in this trial will receive, might help reduce asthma symptoms and improve lung function. Studies have found that it can lower the number of asthma attacks and enhance overall asthma management. Early results indicate that inhaling AZD8630 is safe and generally well-tolerated, making it a promising option for people with asthma. Although these studies are ongoing, the initial findings offer encouragement for those seeking new ways to manage their asthma. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents with asthma. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Asthma control questionnaire-5 (ACQ-5) < 1.5 at Screening and Study Day 1

Pre-bronchodilator Forced expiratory volume in one second (FEV1) ≥ 50% of the predicted normal value

I take asthma medication daily as prescribed by my doctor.

Exclusion Criteria

I am on a stable dose of oral immunotherapy.

I have a history of a significant health condition.

My asthma is severe and life-threatening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single inhaled dose of AZD8630 via dry powder inhaler

1 day

1 visit (in-person)

Post Treatment

Participants are monitored for pharmacokinetics, safety, and immunogenicity

8 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AZD8630

Trial Overview The study tests a single inhaled dose of AZD8630 using a dry powder inhaler to see how it's processed by the body, its safety, tolerability, and if it causes an immune response in young people with asthma.

How Is the Trial Designed?

Group I: AZD8630 Experimental Treatment 2 Interventions

Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06529419

NCT06529419 | A Dose Range-Finding Study to Assess ... This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 ...

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6830C00003

A Dose Range-Finding Study to Assess the Efficacy and ... A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with ...

3. clinicaltrials.eu clinicaltrials.eu/inn/azd8630/

AZD8630: A Promising New Treatment for Asthma Improved asthma control: The medication may help reduce asthma symptoms and improve lung function. · Reduced exacerbations: AZD8630 is being studied for its ...

4. withpower.com withpower.com/trial/azd8630-for-uncontrolled-asthma-0cae6

AZD8630 for Uncontrolled Asthma (Levante Trial) The research on tezepelumab, a drug used for severe, uncontrolled asthma, shows it can reduce asthma attacks by up to 71% and improve lung function and quality ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05110976

NCT05110976 | A Study to Investigate the Safety, ... This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults.

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6830C00001

A Study to Investigate the Safety, Tolerability and Effects of ... This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part ...

7. publications.ersnet.org publications.ersnet.org/content/erj/64/suppl68/pa3558

Pharmacokinetics of AZD8630/AMG 104 inhaled anti-TSLP in ... This Phase1 study (NCT05110976) aimed to characterize safety, tolerability, pharmacokinetics (PK) and immunogenicity of AZD8630/AMG 104 in healthy volunteers ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06795906

Study Details | NCT06795906 | A Safety, Pharmacokinetic, ... The purpose of this study is to assess the safety, PK, and PD of AZD8630 compared to placebo in participants with asthma and elevated fractional exhaled nitric ...