RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 moderate to very severe chronic obstructive pulmonary disease.

Official Title

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-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)

Quick Facts

Study Start:2025-06-27
Study Completion:2027-11-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07082738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be ≥40 years of age at the time of signing the informed consent.
  2. * Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
  3. * 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.
  4. * Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
  5. * Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
  6. * CAT score ≥ 10 at Visit 1.
  7. * Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
  8. * Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
  9. * Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
  1. * 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).
  2. * Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
  3. * 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.
  4. * Significant left heart failure.
  5. * 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.
  6. * Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
  7. * History of another underlying condition that predisposes the participant to infections.
  8. * History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
  9. * Abnormal laboratory findings.
  10. * Participants with evidence of active liver disease and/or evidence of chronic liver disease.
  11. * Participants with history of HIV infection or who test positive for HIV.
  12. * History of lung volume reduction surgery.
  13. * Current or history of malignancy within 5 years before the screening visit.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Dave Singh, MD
PRINCIPAL_INVESTIGATOR
Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85027
United States
Research Site
Phoenix, Arizona, 85044
United States
Research Site
Phoenix, Arizona, 85051
United States
Research Site
Canoga Park, California, 91303
United States
Research Site
La Mesa, California, 91942
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Norco, California, 92860
United States
Research Site
Tustin, California, 92780
United States
Research Site
Lakewood, Colorado, 80228
United States
Research Site
Cape Coral, Florida, 33990
United States
Research Site
Clearwater, Florida, 33756
United States
Research Site
Clearwater, Florida, 33765
United States
Research Site
Jacksonville, Florida, 32216
United States
Research Site
Lake City, Florida, 32055
United States
Research Site
Miami Lakes, Florida, 33014
United States
Research Site
Miami, Florida, 33125
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Miami, Florida, 33173
United States
Research Site
Miami, Florida, 33175
United States
Research Site
Miami, Florida, 33182
United States
Research Site
Naples, Florida, 34102
United States
Research Site
Ocala, Florida, 34471
United States
Research Site
Ormond Beach, Florida, 32174
United States
Research Site
Plantation, Florida, 33324
United States
Research Site
Sarasota, Florida, 34239
United States
Research Site
Tamarac, Florida, 33321
United States
Research Site
Tampa, Florida, 33606
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
Winter Park, Florida, 32789
United States
Research Site
Suwanee, Georgia, 30024
United States
Research Site
West Des Moines, Iowa, 50266
United States
Research Site
Lexington, Kentucky, 40503
United States
Research Site
Zachary, Louisiana, 70791
United States
Research Site
Garden City, Michigan, 48135
United States
Research Site
Grand Rapids, Michigan, 49546
United States
Research Site
Chesterfield, Missouri, 63005
United States
Research Site
Hannibal, Missouri, 63401
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Saint Louis, Missouri, 63141
United States
Research Site
Kalispell, Montana, 59901
United States
Research Site
Mount Kisco, New York, 10549
United States
Research Site
New Bern, North Carolina, 28562
United States
Research Site
Cleveland, Ohio, 44106
United States
Research Site
Marion, Ohio, 43302
United States
Research Site
Oklahoma City, Oklahoma, 73104
United States
Research Site
Tulsa, Oklahoma, 74133
United States
Research Site
Portland, Oregon, 97202
United States
Research Site
Camp Hill, Pennsylvania, 17011
United States
Research Site
DuBois, Pennsylvania, 15801
United States
Research Site
Philadelphia, Pennsylvania, 19114
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
Scottdale, Pennsylvania, 15683
United States
Research Site
Smithfield, Pennsylvania, 15478
United States
Research Site
Lancaster, South Carolina, 29720
United States
Research Site
Chattanooga, Tennessee, 37421
United States
Research Site
Johnson City, Tennessee, 37604
United States
Research Site
Boerne, Texas, 78006
United States
Research Site
Dallas, Texas, 75254
United States
Research Site
Denison, Texas, 75020
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
Houston, Texas, 77002
United States
Research Site
Houston, Texas, 77008
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
Pearland, Texas, 77584
United States
Research Site
Norfolk, Virginia, 23504
United States
Research Site
Williamsburg, Virginia, 23188
United States
Research Site
Morgantown, West Virginia, 26505
United States
Research Site
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Dave Singh, MD, PRINCIPAL_INVESTIGATOR, Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27
Study Completion Date2027-11-05

Study Record Updates

Study Start Date2025-06-27
Study Completion Date2027-11-05

Terms related to this study

Keywords Provided by Researchers

  • COPD
  • Moderate COPD
  • Severe COPD
  • Very Severe COPD
  • chronic obstructive pulmonary disease
  • AZD6793
  • IRAK4

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease (COPD)