RecruitingPhase 2

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well two doses of AZD6793 work and how safe they are compared with placebo tablets, which have no active study drug. It is for adults age 40 or older with moderate to very severe COPD, a long-term lung disease that makes breathing hard.

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older, with a documented COPD diagnosis for at least 12 months.
  • Breathing tests must meet study limits before and after medicine that opens the airways. After medicine, the amount blown out in one second must be 25% to less than 80% of the expected normal amount.
  • At least 2 moderate COPD flare-ups or 1 severe flare-up in the past 12 months.
  • On a stable daily treatment plan with two or three inhaled medicines for at least 3 months.
  • A score of at least 10 on the COPD Assessment Test, which measures symptoms, at Visit 1.
  • Currently smoke or used to smoke, with at least 10 pack-years of cigarette use—for example, 1 pack a day for 10 years.
  • Health must be stable, with no COPD flare-up for at least 4 weeks before Visit 1 and before Visit 3, when treatment is assigned.
  • Women who can become pregnant must have negative pregnancy tests at Visits 1 and 3.

Who can't join

  • Another important lung disease besides COPD, such as asthma, an active lung infection, lung scarring, or cystic fibrosis; or scans showing another disease that greatly adds to breathing symptoms.
  • Any unstable health disorder, or major problems with physical abilities, memory, or thinking.
  • Significant heart failure; certain serious heart or valve problems; uncontrolled heartbeat problems; fluid buildup; or unstable chest pain, a heart attack, or a procedure to open or bypass heart arteries within 6 months before treatment assignment.
  • Certain types of high blood pressure in the arteries of the lungs, or past surgery to reduce lung size.
  • A condition that raises the risk of infections, a history of HIV infection, or a positive HIV test.
  • A history of ulcerative colitis, Crohn’s disease, or microscopic colitis—diseases that cause swelling in the bowel.
  • Abnormal lab test results, or signs of active or long-term liver disease.
  • Cancer now or within 5 years before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participant must be ≥40 years of age at the time of signing the informed consent. * Documented primary diagnosis of COPD for at least 12 months prior to enrolment. * Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of predicted normal at Visit 2. * Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening. * Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening. * CAT score ≥ 10 at Visit 1. * Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years. * Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation). * Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP). Exclusion Criteria: * Clinically important pulmonary disease other than COPD (eg, asthma \[current diagnosis per GINA or other accepted guidelines\], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia). * Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. * Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment. * Significant left heart failure. * Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload. * Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease. * History of another underlying condition that predisposes the participant to infections. * History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology. * Abnormal laboratory findings. * Participants with evidence of active liver disease and/or evidence of chronic liver disease. * Participants with history of HIV infection or who test positive for HIV. * History of lung volume reduction surgery. * Current or history of malignancy within 5 years before the screening visit.

Study sites (86)

AL

AZ

CA

CO

FL

GA

IA

KY

LA

MA

MD

MI

MO

MT

NC

NY

OH

OK

OR

PA

SC

SD

TN

TX

VA

VT

WI

WV