Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis (STRATUS)

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Bronchiectasis

Respiratory Diseases

Lung Disease

Treatments

Drug: AZD5069

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

D3550C00014

Details and patient eligibility

About

The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.

Enrollment

83 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
Aged 18 to 80 years inclusive at screening (Visit 1)
Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
Be on a stable treatment regimen, as judged by the investigator.

Exclusion criteria

Any clinically significant disease or disorder
Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
An FEV1 of <30% of predicted normal at Visit 1
Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate