Tests inhaled CSL787 in adults with non-cystic fibrosis bronchiectasis
Tests an inhaled antibody treatment against placebo in adults with bronchiectasis.
Plain-language title generated from the registry record
Registry title: Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Key facts
- Where
- Barcelona, Girona, Lleida, Logroño, Pozuelo de Alarcón, Sant Boi de Llobregat, Santiago de Compostela, and Valladolid, SpainSee the 9 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-cystic fibrosis bronchiectasis who have had recent flare-ups needing antibiotics and who can bring up sputum on their own.
- Age
- 18 to 85 years
- Sex
- All sexes
- Disease stage
- Bronchiectasis (not caused by cystic fibrosis) confirmed by a chest CT scan. In the past year: at least 2 flare-ups treated with antibiotics, or 1 flare-up plus a St. George's Respiratory Questionnaire Symptoms score above 40. Lung function: FEV1% above 35% and FEV1 of at least 1 L.
- Earlier treatment
- Oral macrolides or DPP-1 inhibitors are allowed if a flare-up happened while taking them for at least 3 months at a stable dose. No antibiotics for a lung flare-up or any other condition in the 4 weeks before Day 1.
Main reasons for not taking part
- History of severe or uncontrolled asthma, or airway tightening (bronchospasm) from inhaled treatments
- Known or suspected allergy to the study product, its ingredients, or other immunoglobulins
- Main diagnosis of another lung disease, such as COPD, asthma or diffuse panbronchiolitis
- Antibiotic use in the 4 weeks before Day 1
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07048262, who can take part
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainNot yet recruiting
- Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
- Hospital Universitari de Girona Doctor Josep TruetaGirona, SpainNot yet recruiting
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De LleidaLleida, SpainNot yet recruiting
- Hospital San PedroLogroño, SpainNot yet recruiting
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainNot yet recruiting
- Parc Sanitari Sant Joan de DéuSant Boi de Llobregat, SpainNot yet recruiting
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainNot yet recruiting
- Hospital Universitario Rio HortegaValladolid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CSL Behring
- Trial code
- NCT07048262EU 2024-518821-13-00
- Record updated
- 19 October 2026
- Original description
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (human normal immunoglobulin G [IgG] inhalation solution) compared with placebo over 52 weeks.Read full original descriptionShow less
A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 Years) With Non-cystic Fibrosis Bronchiectasis
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (human normal immunoglobulin G [IgG] inhalation solution) compared with placebo over 52 weeks.
The primary aim of the study is to characterize the overall effect of CSL787 as well as the dose response of 2 active treatment regimens of inhaled CSL787 administered to participants with NCFB toward prolonging the time to first (TTF) exacerbation.
Inclusion: Adult between the ages of 18 to 85 years; Capable of spontaneous sputum production at Screening; 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 documented 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 one of the following:; greater than or equal (≥) 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) Symptoms score of greater than (>) 40 at Screening; Note: Other medications to treat NCFB such as: 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 percent predicted forced expiratory volume in 1 second (FEV1%) > 35% and forced expiratory volume in 1 second (FEV1) ≥ 1 L obtained in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline on Day 1.
Exclusion: Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other immunoglobulins; Use of oral, IV, or inhaled antibiotic therapy to treat a pulmonary exacerbation or any other condition within 4 weeks before Baseline measurements on Day 1; History of severe or uncontrolled asthma, or 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.