Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COPD Exacerbation
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participating patients with AECOPD will be randomized 1:1 to either a standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours or nebulized Revefenacin 175 ?g once per day and Formoterol 20 ?g twice per day. Each patient will have a single randomization number indicating the allocated treatment. The treatment assignments will be generated with the use of a pseudo-random-number generator with stratification for age groups (<50, 50-69, >70) that will be used to ensure balance of these factors in the numbers of subjects assigned to each of the two treatments. The allocation to treatment arms will be according to a predetermined computer-generated randomization schedule that will not be disclosed to the clinical investigators.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Description
A prospective, parallel group, randomized clinical trial in 60 patients hospitalized with the primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD (ICD-10 codes J44.1 and J96 - J96.2 with J44.9). The plan is to: Administer standard bronchodilator protocol with ...
A prospective, parallel group, randomized clinical trial in 60 patients hospitalized with the primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD (ICD-10 codes J44.1 and J96 - J96.2 with J44.9). The plan is to: Administer standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours (n=30) versus Nebulized Revefenacin 175 ?g once per day and Formoterol 20 ?g twice per day (n=30) for up to 7 days of treatment. Study medication will be administered by standard jet nebulizers in both groups. Investigators will: Collect the Borg dyspnea scale twice a day during hospitalization Record the total doses of bronchodilators per day received by each patient Record the number of rescue doses needed per day of hospital stay Record the lowest level of FiO2 employed on days 1, 3 and 7 of hospital stay Record all adverse events and concurrent medications Investigators will collect: Physical Exam (Day 1, 3, 7, or ET) Serum Chemistry (Day 1, 3, 7, or ET) Hematology (Day 1, 3, 7, or ET) Chest X-Ray (Day 1).
Tracking Information
- NCT #
- NCT04655170
- Collaborators
- Mylan Pharmaceuticals
- Investigators
- Not Provided
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