A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mi… (NCT07076290) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD
27 participantsStarted 2026-09-01
Plain-language summary
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)
Who can participate
Age range40 Years – 82 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society.
* Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of \<0.70 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1\>20% and ≤80% of predicted normal values
* Baseline mMRC dyspnea score 1 to 3
* Post-bronchodilator FEV1 \> 50% predicted (GOLD COPD grade 1-2)
* Smoking pack years ≥ 10 years
* Age ≥ 40 years
* Acceptable standard-of-care COPD maintenance therapy includes long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), or combinations thereof (e.g., dual LABA/LAMA, or triple LABA/LAMA/ICS therapy). The patient must have been on a stable dose and regimen for at least 4 weeks prior to screening with no changes anticipated during the study unless medically necessary.
* A history of ≥ 1 exacerbations in the last 12 months
* Be able to provide written consent; compliant with study procedures and study visits.
Exclusion Criteria:
* Patients whose treatment is considered palliative (life expectancy \<12 months) Comorbid severe lung disease, such as bronchiectasis, pulmonary fibrosis
* Current smoker or cessation within 3 months of screening, or current use of vaping device
* Patients with pneumonia or COPD exacerbat…
What they're measuring
1
To assess the treatment-related adverse events of R-3750