Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Korábbi kezelés

• Current or prior history of asthma.
• 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
• 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,

Más betegség

• Interstitial lung disease.
• Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)

Egyéb

• 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
• Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.
• Has a weight >120 kg at Screening.
• Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
• Has systemic immunosuppression/immune deficiency

• 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.