"The Effect of Inhaled Nitroglycerin for COPD Patients

NCT ID: NCT06785337

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD COPD III/IV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

Inhaled nitroglycerin

Intervention Type DRUG

Inhaled nitroglycerin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inhaled nitroglycerin

Inhaled nitroglycerin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asia Said Toukhy

assistant lecturer in clinical pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haram Hospital

Haram, Giza Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

asia said Toukhy, head of clinical pharmacy

Role: primary

01127424017

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34479748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37303880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33560642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20442544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33937932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38490779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28454823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28236803 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC-H-PhBSU-24020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Nitrite and Coronary Flow Study
NCT04354051 COMPLETED PHASE1/PHASE2
Nitrite Infusion Studies
NCT00102271 COMPLETED PHASE1