Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGRLS-0071
RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.
DRUGPlacebo
Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.
Sponsors
ReAlta Life Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1 ≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause. * Participants must have a moderate exacerbation of COPD according to the Rome guidelines * ≥ 10 pack-years smoking history.
Exclusion criteria
* Endotracheal intubation or mechanical ventilation. * Participants with severe exacerbation of COPD according to the Rome guidelines * Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status * Interstitial lung disease. * Current or prior history of asthma. * Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG) * Preexisting autoimmune disease: History of autoimmune disease and/or use of chronic steroids of \>10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment * Current renal dialysis or renal dialysis planned or anticipated in the next 7 days. * Has confounding medical conditions, including: 1. diabetic coma, 2. uncontrolled New York Heart Association Class IV congestive heart failure, 3. uncontrolled angina, 4. stroke or transient ischemic attack (TIA) within 4 weeks before study entry, 5. clinically significant arrhythmias not controlled by medication, or 6. idiopathic pulmonary fibrosis, * Has a weight \>120 kg at Screening. * Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP. * Has systemic immunosuppression/immune deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 to Day 60 |
Secondary
| Measure | Time frame |
|---|---|
| Measure the % O2 saturation via pulse oximetry daily | Day 1 - Up to Day 5 |
| Time to reach maximum observed serum concentration (Tmax) for RLS-0071 | Day 1 and Day 3 |
| Maximum Observed Serum Concentration (Cmax) for RLS-0071 | Day 1 and Day 3 |
| Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071 | Day 1 and Day 3 |
| Terminal Phase Elimination Half-Life (t1/2) for RLS-0071 | Day 1 and Day 3 |
| Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5. | Day 0 up to Day 5. |
| Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5. | Day 0 up to Day 5. |
| Measure respiratory rate by measuring breaths per minute daily | Day 1 - Up to Day 5 |
| Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5. | Day 0 up to Day 5. |
| Number of days participant was hospitalized (length of stay). | Day 1 - Day 60 |
| Number of participants rehospitalized for COPD up to Day 60 | Day 1 to Day 60 |
| Number of participants that progressed to mechanical ventilation | Day 1 - Day 5 |
| Mortality rate of participants at 60 days after discharge | Day 1 to Day 60 |
| Measure heart rate via beats per minute daily | Day 1 - Up to Day 5 |
| Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5. | Day 0 up to Day 5. |
Countries
United States
Outcome results
None listed