"The Effect of Inhaled Nitroglycerin for COPD Patients

Phase 2

Recruiting

• Conditions: COPD; COPD III/IV
• Interventions: Drug: Inhaled nitroglycerin

• Registration Number: NCT06785337
• Lead Sponsor: Beni-Suef University

Brief Summary

this study aims to investigative the benefits of using nebulized nitroglycerin in improving respiratory functions in patients of late stage COPD

Detailed Description

the inhaled nitroglycerin is expected to make vasodilatation of the pulmonary arteries and arterioles which are constricted in late stages of COBD leading to ventilation/perfusion mismatching and further aggravating COPD. it will also help in delivering better antibiotic concentrations to the alveoli which help in better control of infection.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-18
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-23
• Study Start: 2025-02-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patient's ≥ 18 years old COPD exacerbation with respiratory failure and Echo evidenced presence of pulmonary hypertension (defined as mean pulmonary artery pressure > 20 mmHg)

Exclusion Criteria

• Profound left ventricular failure, as the decrease in pulmonary vascular resistance results in an increase in left ventricular preload. This may worsen cardiogenic pulmonary edema.
• Pregnant female patients
• Patient with hypersensitivity to nitroglycerin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Inhaled nitroglycerin	will receive inhaled nitroglycerin in addition to standard COPD exacerbation treatment protocol

Primary Outcome Measures

Name	Time	Method
Change in pulmonary functions	5 days after start of nebulized nitroglycerin	Change in pulmonary functions Defined as: * Reduction of PaCO2 in arterial blood gases from admission value.; * increase in Pao2 from admission value.

Secondary Outcome Measures

Name	Time	Method
Number of days on mechanical ventilation	5 days after start of nebulized nitroglycerin
Dose of vasopressor therapy	5 days after start of nebulized nitroglycerin
Reduction of WBC count	10 days after start of nebulized nitroglycerin
Mortality rate	10 days after start of nebulized nitroglycerin

Trial Locations

Locations (1)

Haram Hospital; 🇪🇬 Haram, Giza, Egypt