Studying Inhaled Nitroglycerin to Improve Breathing in Adults with Severe COPD and Lung Blood Vessel High Pressure
Led by Beni-Suef University · Updated on 2025-01-23
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of inhaled nitroglycerin on improving respiratory function in patients with late-stage Chronic Obstructive Pulmonary Disease COPD, especially those experiencing respiratory failure and pulmonary hypertension. The study aims to investigate how this treatment may help by dilating pulmonary arteries to reduce ventilationperfusion mismatch and improve antibiotic delivery to the lungs. This trial is sponsored by Beni-Suef University and includes patients admitted to adult intensive care units.
Participants will be randomly assigned to one of two groups. One group will receive the standard treatment for COPD exacerbation, including antibiotics, corticosteroids, and bronchodilators. The other group will receive inhaled nitroglycerin in addition to the standard treatment. The study is designed as a phase 2 and phase 3 trial, with no blinding, and will monitor the effects over several days.
During the study, participants will be closely monitored for changes in pulmonary function five days after starting the inhaled nitroglycerin. Researchers will also track the number of days on mechanical ventilation, the dose of vasopressor therapy, reduction in white blood cell count, and mortality rate up to ten days after treatment begins. The study aims to understand the treatments impact on respiratory failure in COPD patients and will continue until December 2025.
CONDITIONS
Brief Title
"The Effect of Inhaled Nitroglycerin for COPD Patients
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Adult patients 18 years or older with COPD exacerbation and respiratory failure
Echocardiogram evidence of pulmonary hypertension (mean pulmonary artery pressure over 20 mmHg)
You will not qualify if you...
Profound left ventricular failure
Pregnant female patients
Known hypersensitivity to nitroglycerin
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 5 to 10 days
Participants receive inhaled nitroglycerin in addition to standard COPD exacerbation treatment including antibiotics, corticosteroids, and bronchodilators to improve respiratory failure.
Daily treatment visits for up to 10 days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
COVID-19 Acute Respiratory Distress Syndrome and Pulmonary Embolism: A Case Report of Nebulized Nitroglycerin and Systemic Thrombolysis For Right Ventricular Failure.
Benjamin Karfunkle, Joseph Gill, Stephanie Shirey...
Acute hemodynamic effects of inhaled nitroglycerine, intravenous nitroglycerine, and their combination with intravenous dobutamine in patients with secondary pulmonary hypertension.