Resumen

Este estudio de determinación de dosis de fase IIb evaluará la eficacia y seguridad de 3 dosis diferentes de AZD6793 en comparación con comprimidos de placebo en participantes con enfermedad pulmonar obstructiva crónica moderada a muy grave.

Descripción detallada

Estudio multicéntrico, en grupos paralelos, de fase IIb, aleatorizado, doble ciego, controlado con placebo, con 4 brazos y 24 semanas de duración, para evaluar la eficacia y seguridad de los comprimidos de AZD6793 en participantes adultos con enfermedad pulmonar obstructiva crónica moderada a muy grave (PRESTO) Aproximadamente 400 centros a nivel mundial participarán en este estudio. Aproximadamente 1160 participantes serán aleatorizados en cuatro grupos de tratamiento: tres dosis diferentes de AZD6793 frente a placebo en una proporción 1:1:1:1.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

AZD6793

Placebo

Ubicaciones

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Patrocinadores

Contactos

AstraZeneca Clinical Study Information Center