"The Effect of Inhaled Nitroglycerin for COPD Patients (iNGCOPD)

January 20, 2025 updated by: Asia Said Toukhy, Beni-Suef University

"The Effect of Inhaled Nitroglycerin on Improving Respiratory Failure in COPD Patients Admitted to Adult Intensive Care Unit"

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Haram, Giza, Egypt, 12556
        • Recruiting
        • Haram Hospital
        • Contact:
          • asia said Toukhy, head of clinical pharmacy
          • Phone Number: 01127424017
          • Email: asia_said@yahoo.com
        • Contact:
          • Asia said Toukhy, assistant lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
will receive standard COPD exacerbation treatment protocol including antibiotics, corticosteroids and bronchodilator only
Experimental: Intervention group
will receive inhaled nitroglycerin in addition to standard COPD exacerbation treatment protocol
Drug: Inhaled nitroglycerin
Inhaled nitroglycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pulmonary functions
Time Frame: 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.
5 days after start of nebulized nitroglycerin

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of days on mechanical ventilation
Time Frame: 5 days after start of nebulized nitroglycerin
5 days after start of nebulized nitroglycerin
Dose of vasopressor therapy
Time Frame: 5 days after start of nebulized nitroglycerin
5 days after start of nebulized nitroglycerin
Reduction of WBC count
Time Frame: 10 days after start of nebulized nitroglycerin
10 days after start of nebulized nitroglycerin
Mortality rate
Time Frame: 10 days after start of nebulized nitroglycerin
10 days after start of nebulized nitroglycerin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-H-PhBSU-24020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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