Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults with Non-cystic Fibrosis Bronchiectasis (NCFB)
EU CTIS ID: 2024-518821-13-00
What this study is testing
To evaluate the effect of nebulized CSL787 (human normal immunoglobulin for nebulization) on the TTF exacerbation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult between the ages of 18 to 85 years
- 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
- Exacerbation history within the previous 1 year defined as either 1 of the following: − >= 2 documented exacerbations requiring oral and / or intravenous (IV) antibiotic therapy to treat a pulmonary infection. OR − 1 documented exacerbation requiring oral and / or IV antibiotic therapy to treat a pulmonary infection and a St. George’s Respiratory Questionnaire (SGRQ) total score > 40 at Screening. Note: Other medications to treat NCFB such as: maintenance treatment with oral macrolides, or dipeptidyl peptidase-1 (DPP-1) inhibitors are allowed, provided >= 1 historical exacerbation occurred while on the medication for >= 3 months at a stable dose
- 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 (L) obtained in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline.
You likely can't join if
- History of bronchospasm in response to inhaled therapies including inhaled antibiotics
- Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma or, diffuse panbronchiolitis (DPB), as determined by the investigator.
- Pulmonary exacerbation requiring antibiotic therapy within the 6 weeks before Baseline.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
- Japan
- Korea, Democratic People's Republic of
- Australia
- United Kingdom
- New Zealand
- Singapore
- Canada
- Argentina
- Taiwan
- Chile
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey; Japan; Korea, Democratic People's Republic of; Australia; United Kingdom and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.