A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-82
SponsorRise Therapeutics LLC
About this trial
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)
Eligibility criteria
Qualifiers
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)
Disqualifiers
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 exacerbation or lower respiratory infections within the 4 weeks prior to study Day 1
Uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure [e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnea), and class IV (e.g. Symptoms of heart failure at rest)] that will affect the study.
Trial design
Treatments tested in this trial
- R-3750
Treatment groups
27 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov