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Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
RECRUITINGPhase 4Sponsored by University of Tennessee Graduate School of Medicine
Actively Recruiting
PhasePhase 4
SponsorUniversity of Tennessee Graduate School of Medicine
Started2020-12-09
Est. completion2023-01-30
Eligibility
Age40 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04655170
Summary
The purpose of this study is to assess the feasibility, safety and efficacy of a combination of nebulized Formoterol and Revefenacin among patients hospitalized for AECOPD compared with standard-of-care therapy with nebulized Albuterol and Ipratropium.
Eligibility
Age: 40 Years+Healthy volunteers accepted
Inclusion Criteria: 1. Male or Female 2. Any Race 3. ≥ 40 years of age 4. Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD 5. Able to understand and comply with study procedures 6. Willingness to sign and date an Informed Consent Form Exclusion Criteria: 1. Patients unable or unwilling to sign an informed consent or cooperate with study procedures 2. Patients who are hypersensitive to Formoterol or Revefenacin 3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway 4. Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support 5. Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled, hypertension, unstable angina, recent MI (within 12 weeks), ventricular arrhythmia, or decompensated heart failure) 6. Patients with a current diagnosis of lung cancer requiring treatment 7. Patients that test positive for COVID-19 8. Pulmonary diseases other than COPD, or lobar pneumonia 9. Patients with acute psychiatric illness deemed significant by the investigator 10. Patients with a history of glaucoma deemed significant by the investigator 11. History of urinary retention deemed significant by the investigator 12 Women who are pregnant or breast feeding
Conditions2
COPDCOPD Exacerbation
Interventions1
Locations1 site
University of Tennessee Medical Center
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Actively Recruiting
PhasePhase 4
SponsorUniversity of Tennessee Graduate School of Medicine
Started2020-12-09
Est. completion2023-01-30
Eligibility
Age40 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04655170