Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT01255592
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01255592
Study Brief:
Protocol Section:
NCT01255592