1160 Participants Needed

AZD6793 for COPD

(PRESTO Trial)

Recruiting at 272 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
Must be taking: Inhaled maintenance therapy
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AZD6793, to evaluate its effectiveness and safety for people with chronic obstructive pulmonary disease (COPD). Researchers aim to determine the best dose among three options by comparing them to a placebo (a pill with no active medicine). This trial suits individuals who have had moderate to very severe COPD for at least a year, experience frequent flare-ups, and are already on a stable inhaler routine. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in COPD treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires a stable regimen of inhaled maintenance therapy for at least 3 months before screening.

Is there any evidence suggesting that AZD6793 is likely to be safe for humans?

Research has shown that AZD6793 underwent safety testing in earlier studies. These studies assessed how well participants tolerated the drug in single doses. Results indicated that AZD6793 was generally well-tolerated, with no major safety concerns reported. This treatment targets chronic obstructive pulmonary disease (COPD) by blocking specific pathways involved in the disease. While earlier tests suggest safety, the current trial aims to gather more detailed information. Specifically, the researchers are evaluating the safety and effectiveness of different doses.12345

Why do researchers think this study treatment might be promising for COPD?

Researchers are excited about AZD6793 for COPD because it potentially offers a new approach compared to standard treatments like bronchodilators and corticosteroids. While most current therapies aim to open airways and reduce inflammation, AZD6793 might work by specifically targeting new pathways involved in the disease's progression. This innovative mechanism could lead to better control of symptoms and possibly slow disease progression. If successful, AZD6793 could provide a much-needed alternative for patients who do not respond well to existing treatments.

What evidence suggests that AZD6793 might be an effective treatment for COPD?

Research suggests that AZD6793 might help people with COPD (chronic obstructive pulmonary disease) by improving lung function. Studies have found that AZD6793 targets specific body parts to reduce inflammation, a major issue in COPD. In early animal tests, the drug reduced symptoms like shortness of breath and coughing. Although detailed information from human studies remains limited, early trials showed the drug is generally safe and doesn't cause serious side effects. Researchers continue to investigate these benefits, but initial results are promising for those with moderate to very severe COPD.12356

Who Is on the Research Team?

DS

Dave Singh, MD

Principal Investigator

Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom

Are You a Good Fit for This Trial?

This trial is for people with moderate to very severe chronic obstructive pulmonary disease (COPD). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP)
I have been diagnosed with COPD ranging from moderate to very severe for over a year.
I am 40 years old or older.
See 6 more

Exclusion Criteria

I do not have any unstable health conditions.
I have severe heart failure.
I have lung problems not caused by COPD affecting my breathing.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three doses of AZD6793 or placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AZD6793
Trial Overview The study is testing three different doses of a medication called AZD6793 against a placebo. It aims to find out how effective and safe these doses are for treating COPD in a Phase IIb clinical trial setting.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 3 of AZD6793Experimental Treatment1 Intervention
Group II: Dose 2 of AZD6793Experimental Treatment1 Intervention
Group III: Dose 1 of AZD6793Experimental Treatment1 Intervention
Group IV: Matching PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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

A Study to Investigate the Effect of AZD6793 in Participants ...This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with ...
A study to investigate the safety, tolerability, and ...The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD)
NCT05662033 | A Study to Investigate the Safety, ...The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD)
AstraZeneca to showcase latest research on ...COPD pre-clinical data: data evaluates the impact of AZD6793, a ... Chronic Obstructive Pulmonary Disease: Results from the COURSE Study.
5.frfr-prd-astrazeneca-keystone-engage.app-trialscope.comfrfr-prd-astrazeneca-keystone-engage.app-trialscope.com/study/D7860C00006/
A study to investigate the effect of AZD6793 in participants ...This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in ...
AZD6793 / AstraZenecaAZD6793, a novel IRAK4 inhibitor, targets multiple disease-relevant pathways in pre-clinical models of chronic obstructive pulmonary disease (ATS 2025).
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