AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.
This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Site 02
St. Petersburg, Florida, United States
Site 03
Glen Burnie, Maryland, United States
Site 04
Omaha, Nebraska, United States
Site 01
Philadelphia, Pennsylvania, United States
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to Day 60
Time to reach maximum observed serum concentration (Tmax) for RLS-0071
Time frame: Day 1 and Day 3
Maximum Observed Serum Concentration (Cmax) for RLS-0071
Time frame: Day 1 and Day 3
Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071
Time frame: Day 1 and Day 3
Terminal Phase Elimination Half-Life (t1/2) for RLS-0071
Time frame: Day 1 and Day 3
Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.
Time frame: Day 0 up to Day 5.
Number of days participant was hospitalized (length of stay).
Time frame: Day 1 - Day 60
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Number of participants rehospitalized for COPD up to Day 60
Time frame: Day 1 to Day 60
Number of participants that progressed to mechanical ventilation
Time frame: Day 1 - Day 5
Mortality rate of participants at 60 days after discharge
Time frame: Day 1 to Day 60
Measure heart rate via beats per minute daily
Time frame: Day 1 - Up to Day 5
Measure respiratory rate by measuring breaths per minute daily
Time frame: Day 1 - Up to Day 5
Measure the % O2 saturation via pulse oximetry daily
Time frame: Day 1 - Up to Day 5