Bronchiectasis and Pseudomonas aeruginosa Colonization
Conditions
Interventions
[Experimental: High-dose]
High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
- Intervention/Treatment
Biological: AZD0292
AZD0292 high-dose or lo
Sponsors
Ageishi Yuji
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant must be >_ 12 years of age at the time of signing the informed consent/assent 2. Weight >_ 35 kg 3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in >_ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility. 4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of >_ 2 moderate exacerbations or >_ 1 severe exacerbation in the preceding 12 months requiring antibiotics 5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization 6. Participants with pre- or post-bronchodilator FEV1 >_ 25% predicted value at screening. 7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening 8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study. 9. Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Exclusion criteria
Exclusion criteria: 1. Primary lung diagnosis other than bronchiectasis 2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy 3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment 4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed 5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment 6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of 5 mg or equivalent) newly initiated within the last 3 months 10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study 11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Outcome Measure] Annualized rate of exacerbations over a variable follow-up time [Measure Description] To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to-severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA. [Time Frame]Min 28 weeks, max 52 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Peru, Philippines, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed