⚠️ ARCHIVED STUDY: This study is no longer recruiting participants. This information is provided for reference purposes only.
ACT18018 Bronchiectasis Sanofi Trial
The ACT18018 study, sponsored by Sanofi, was designed for patients with non-cystic fibrosis bronchiectasis (NCFB) who experience frequent exacerbations.
Eligibility Criteria
- Age: 18-85 years at the time of informed consent
- Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFB):
- Cough
- Chronic sputum production and/or recurrent respiratory infections
- Confirmed by recent chest CT scan (≤ 5 years old)
- Mucopurulent sputum producers with a history of chronic expectoration
- Pulmonary Exacerbations (PEs) in the past 12 months before Screening:
- At least 2 moderate PEs OR 1 severe PE
- Moderate PE: Worsened respiratory symptoms leading to antibiotic treatment, addition, or change
- Severe PE: Worsened respiratory symptoms resulting in hospitalization or observation for >24 hours
- If on maintenance antibiotics, at least one exacerbation while on therapy
Exclusion Criteria
- Bronchiectasis due to cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis.
- Current tobacco smokers or smoking cessation < 6 months prior to Screening.
- Known or suspected immunodeficiency disorder, including history of invasive/systemic opportunistic infections outside of the lungs.
Study Outcomes
This study has concluded enrollment and is in the data analysis phase. For information about current or upcoming clinical trials for bronchiectasis, please contact our research team.