Clinical trial NCT06785337: "The Effect of Inhaled Nitroglycerin for COPD Patients
Official title: "The Effect of Inhaled Nitroglycerin on Improving Respiratory Failure in COPD Patients Admitted to Adult Intensive Care Unit"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: COPD
COPD III/IV
Keywords: Inhaled
nitroglycerin
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pulmonary functions
timeFrame: 5 days after start of nebulized nitroglycerin
Secondary outcomes:
measure: Number of days on mechanical ventilation
timeFrame: 5 days after start of nebulized nitroglycerin
measure: Dose of vasopressor therapy
timeFrame: 5 days after start of nebulized nitroglycerin
measure: Reduction of WBC count
timeFrame: 10 days after start of nebulized nitroglycerin
measure: Mortality rate
timeFrame: 10 days after start of nebulized nitroglycerin
Other outcomes:
Locations:
city: Haram
country: Egypt
facility: Haram Hospital
state: Giza
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.