Status:
ACTIVE_NOT_RECRUITING
Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
ReAlta Life Sciences, Inc.
Conditions:
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 deve...
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...
Eligibility Criteria
Inclusion
- 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
- 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:
- diabetic coma,
- uncontrolled New York Heart Association Class IV congestive heart failure,
- uncontrolled angina,
- stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
- clinically significant arrhythmias not controlled by medication, or
- 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
Key Trial Info
Start Date :
January 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06175065
Start Date
January 25 2024
End Date
June 1 2025
Last Update
May 8 2025
Active Locations (4)
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1
Site 02
St. Petersburg, Florida, United States, 33701
2
Site 03
Glen Burnie, Maryland, United States, 21061
3
Site 04
Omaha, Nebraska, United States, 68198
4
Site 01
Philadelphia, Pennsylvania, United States, 19122