Revefenacin in Acute Respiratory Insufficiency in COPD

Korábbi kezelés

• For patients taking short- or long-acting muscarinic antagonists (SAMAs or LAMAs) at the time of screening, inability or unwillingness to undergo the SAMA or LAMA washout period (6 hours or 24 hours, respectively) prior to initiating study drug.
• Unwillingness or inability to remain on the study drug with for the duration of the study

Más betegség

• Hypersensitivity to muscarinic antagonists
• Presence of ARDS or acute congestive heart failure
• Documented restrictive lung disease or history of interstitial lung disease
• Known history of glaucoma

Laborértékek

• AST or ALT > 3 times the upper limit of normal, or other clinically significant acute or chronic liver disease

Egyéb

• Chronic invasive mechanical ventilation via tracheostomy. Patients with tracheostomy alone without chronic mechanical ventilation may be enrolled.
• Expected duration of mechanical ventilation <24 hours
• Inability to tolerate albuterol
• Lack of documented COPD history
• Unwillingness or inability to have open-label muscarinic antagonists withheld for duration of the study
• Unwillingness or inability to utilize the Puritan-Bennett 980 (PB980) ventilator
• Pulmonary comorbidities such as pneumothorax or pneumomediastinum that, in the opinion of the investigator or clinical team, can pose a risk to subject safety or interfere with the subject's ability to complete the study procedures.
• Actual body weight exceeding 1 kg per centimeter of height
• Pregnancy
• Enrollment in other interventional clinical trial
• Moribund patient not expected to survive >24 hours
• Decision to withhold life-sustaining treatment, except in those patients committed to full support except cardiopulmonary resuscitation
• Inability to obtain informed consent from patient or legally authorized representative (LAR)

• Adults ≥ 40 years of age
• Acute respiratory failure requiring invasive mechanical ventilation
• Documented history of COPD based on spirometric evidence of FEV1/FVC<70%
• Smoking history >10 years (current or prior)
• Invasive mechanical ventilation for < 96 hours