Non-cystic Fibrosis Bronchiectasis Chronic respiratory disease, Inflammation, Chronic bacterial infection
Conditions
Interventions
CSL787 high dose, CSL787 low dose, or placebo once daily will be administered via inhalation over a period of >= 6 months but not exceeding 12 months.
Sponsors
Akama Hideto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult between the ages of 18 to 85 years 2. Primary diagnosis of NCFB confirmed by chest computed tomography (CT) scan, where bronchiectasis has been documented by a radiologist. Diagnosis in the medical records based on historical scans is acceptable if the chest CT scan confirming the participant's NCFB diagnosis was performed within 12 months before enrollment. Participants for whom no chest CT scan results are available within the previous 12 months will undergo a chest CT scan during the Screening Period 3. Exacerbation history within the previous 1 year defined as either 1 of the following: a) >= 2 documented exacerbations requiring oral and / or intravenous antibiotic therapy to treat a pulmonary infection. OR b).1 documented exacerbation requiring oral and / or IV antibiotic therapy to treat a pulmonary infection and a St. George's Respiratory Questionnaire total score > 40 at Screening. Note: Other medications to treat NCFB such as: maintenance treatment with oral macrolides, or dipeptidyl peptidase-1 inhibitors are allowed, provided >= 1 historical exacerbation occurred while on the medication for >= 3 months at a stable dose. 4. Postbronchodilator percentage of the predicted normal forced expiratory volume in 1 second of expiration (FEV1% predicted) > 35% and forced expiratory volume in 1 second (FEV1) >= 1 liter obtained in accordance with American Thoracic Society / European Respiratory Society standards for spirometry during Screening and at Baseline.
Exclusion criteria
Exclusion criteria: 1. History of bronchospasm in response to inhaled therapies including inhaled antibiotics 2. Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other immunoglobulin. 3. Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma, or diffuse panbronchiolitis (DPB), as determined by the investigator. 4. Pulmonary exacerbation requiring antibiotic therapy within the 6 weeks before Baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Annualized Exacerbation Rate (Exacerbation Event Rate Per Participant-year of Follow-up) 2. Number of Participants Achieving a Clinically Important Difference in the Quality of Life-Bronchiectasis (QoL-B) Respiratory Symptoms Scale 3. Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale 4. Change From Baseline in QoL-B Respiratory Symptoms Scale 5. Change From Baseline in Total Colony-forming Unit for Pathogenic Bacteria Isolated from Sputum 6. Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) 7. Percentage of Participants with TEAEs and SAEs | — |
Countries
Argentina, Australia, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactHideto Akama
CSL Behring K.K.
Outcome results
None listed