A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD

ConditionsCOPD (Chronic Obstructive Pulmonary Disease)COPD Exacerbation COPD Exacerbation Acute

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

R-3750
Drug
R-3750 DP; Lactococcus lactis expressing Surface Layer Protein A (SlpA)

Treatment groups

27 Participants

are divided into 1 treatment group

Group A: Open Label R-3750Other 1 intervention

Trial outcomes

Primary outcomes

To assess the treatment-related adverse events of R-3750

To assess the number of participants with treatment-related adverse events after taking R-3750 (probiotics)

Time frame

12 weeks

Secondary outcomes

Clinical Response based on St. George's Respiratory Questionnaire (SGRQ)

To assess the number of participants that show improvements in the chronic obstructive pulmonary disease (COPD) severity by collecting the St. George's Respiratory Questionnaire (SGRQ). The scores are based on a numbering system ranging from 0-100 where the higher number indicates a worse condition. The scores will be compared from the beginning of the trial and again at different times to the end to see if there are any changes in symptoms before and after taking R-3750 (probiotic).

Time frame

12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rise Therapeutics LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: