"The Effect of Inhaled Nitroglycerin for COPD Patients

NCT06785337 | Recruiting Phase 2 DMC

• 1 other identifier: REC-H-PhBSU-24020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD; COPD III/IV

Keywords

Inhaled; nitroglycerin

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary functions

  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 Outcomes (4)

• 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

Study Arms (2)

Control arm

NO INTERVENTION

will receive standard COPD exacerbation treatment protocol including antibiotics, corticosteroids and bronchodilator only

Intervention group

EXPERIMENTAL

will receive inhaled nitroglycerin in addition to standard COPD exacerbation treatment protocol

Drug: Inhaled nitroglycerin

Interventions

Inhaled nitroglycerin DRUG

Inhaled nitroglycerin

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Haram Hospital

Haram, Giza Governorate, 12556, Egypt

RECRUITING

Related Publications (8)

• Karfunkle B, Gill J, Shirey S, Gordon R. COVID-19 Acute Respiratory Distress Syndrome and Pulmonary Embolism: A Case Report of Nebulized Nitroglycerin and Systemic Thrombolysis For Right Ventricular Failure. J Emerg Med. 2021 Nov;61(5):e103-e107. doi: 10.1016/j.jemermed.2021.07.014. Epub 2021 Jul 9.

  PMID: 34479748 BACKGROUND

• Daunaria DK, Singh GK, Agarwal A, Mishra P. COVID-19-associated acute respiratory distress syndrome (C-ARDS): Inhaled nitroglycerin could be an efficient pulmonary vasodilator. Indian J Anaesth. 2023 Apr;67(4):403-405. doi: 10.4103/ija.ija_635_22. Epub 2023 Apr 10. No abstract available.

  PMID: 37303880 BACKGROUND

• Daxon BT, Lark E, Matzek LJ, Fields AR, Haselton KJ. Nebulized Nitroglycerin for Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome: A Case Report. A A Pract. 2021 Feb 5;15(2):e01376. doi: 10.1213/XAA.0000000000001376.

  PMID: 33560642 BACKGROUND

• Mandal B, Kapoor PM, Chowdhury U, Kiran U, Choudhury M. Acute hemodynamic effects of inhaled nitroglycerine, intravenous nitroglycerine, and their combination with intravenous dobutamine in patients with secondary pulmonary hypertension. Ann Card Anaesth. 2010 May-Aug;13(2):138-44. doi: 10.4103/0971-9784.62946.

  PMID: 20442544 BACKGROUND

• Cai YM, Zhang YD, Yang L. NO donors and NO delivery methods for controlling biofilms in chronic lung infections. Appl Microbiol Biotechnol. 2021 May;105(10):3931-3954. doi: 10.1007/s00253-021-11274-2. Epub 2021 May 3.

  PMID: 33937932 BACKGROUND

• Polzin A, Curtis ED, Rupe E, Sang HI. Inhaled Nitroglycerin for Pulmonary Edema in Air Medical Services: A Retrospective Pilot Study. Air Med J. 2024 Mar-Apr;43(2):151-156. doi: 10.1016/j.amj.2023.11.009. Epub 2023 Dec 19.

  PMID: 38490779 BACKGROUND

• Kline JA, Hall CL, Jones AE, Puskarich MA, Mastouri RA, Lahm T. Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: The iNOPE trial. Am Heart J. 2017 Apr;186:100-110. doi: 10.1016/j.ahj.2017.01.011. Epub 2017 Jan 27.

  PMID: 28454823 BACKGROUND

• Monsalve-Naharro JA, Domingo-Chiva E, Garcia Castillo S, Cuesta-Montero P, Jimenez-Vizuete JM. Inhaled nitric oxide in adult patients with acute respiratory distress syndrome. Farm Hosp. 2017 Mar 1;41(2):292-312. doi: 10.7399/fh.2017.41.2.10533.

  PMID: 28236803 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in clinical pharmacy

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 21, 2025
• Study Start: February 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2024-11

Locations

EG (1)