COPDPhase 2/3iNGCOPDNCT06785337
"The Effect of Inhaled Nitroglycerin for COPD Patients
A Phase 2/3 study testing Inhaled nitroglycerin in people with COPD and COPD III/IV, run by Beni-Suef University at 1 site in Egypt.
Trial summary
this study aims to investigative the benefits of using nebulized nitroglycerin in improving respiratory functions in patients of late stage COPD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD III/IV
- What is being tested?
- Inhaled nitroglycerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Haram Hospital
Haram, Giza Governorate, 12556
asia said Toukhy, head of clinical pharmacy, 01127424017, asia_said@yahoo.com
Asia said Toukhy, assistant lecturer
About this study
Official title: "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
Read the 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.
- Conditions
- COPD, COPD III/IV
- Being tested
- Inhaled nitroglycerin
- Keywords
- Inhaled, nitroglycerin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitroglycerinDrug
Inhaled nitroglycerin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Inhaled nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days after start of nebulized nitroglycerin
Secondary outcomes (4)
Number of days on mechanical ventilation
Measured: 5 days after start of nebulized nitroglycerin
Dose of vasopressor therapy
Measured: 5 days after start of nebulized nitroglycerin
Reduction of WBC count
Measured: 10 days after start of nebulized nitroglycerin
Mortality rate
Measured: 10 days after start of nebulized nitroglycerin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asia Said Toukhy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785337
- Sponsor's protocol ID
- REC-H-PhBSU-24020
- Acronym
- iNGCOPD
- Status last verified
- Nov 2024
- First submitted
- 6 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34479748Daunaria 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.
PubMed 37303880Daxon 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.
PubMed 33560642Mandal 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.
PubMed 20442544Cai 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.
PubMed 33937932Polzin 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.
PubMed 38490779Kline 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.
PubMed 28454823Monsalve-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.
PubMed 28236803
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Inhaled Nitroglycerin on Improving Respiratory Failure in COPD Patients Admitted to Adult Intensive Care Unit"
- ClinicalTrials.gov ID
- NCT06785337
- Acronym / sponsor ID
- iNGCOPD / REC-H-PhBSU-24020
- Conditions
- COPD, COPD III/IV
- Keywords
- Inhaled, nitroglycerin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –will receive standard COPD exacerbation treatment protocol including antibiotics, corticosteroids and bronchodilator only |
| Intervention group | Experimental | Drug: Inhaled nitroglycerinwill receive inhaled nitroglycerin in addition to standard COPD exacerbation treatment protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled nitroglycerinInhaled nitroglycerin | Drug | Intervention group |
Primary outcome
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.
4 secondary outcomes
Number of days on mechanical ventilation
Time frame: 5 days after start of nebulized nitroglycerin
Dose of vasopressor therapy
Time frame: 5 days after start of nebulized nitroglycerin
Reduction of WBC count
Time frame: 10 days after start of nebulized nitroglycerin
Mortality rate
Time frame: 10 days after start of nebulized nitroglycerin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Results publication: PubMed 34479748Karfunkle 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.
- Results publication: PubMed 37303880Daunaria 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.
- Results publication: PubMed 33560642Daxon 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.
- Results publication: PubMed 20442544Mandal 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.
- Results publication: PubMed 33937932Cai 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.
- Results publication: PubMed 38490779Polzin 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.
- Results publication: PubMed 28454823Kline 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.
- Results publication: PubMed 28236803Monsalve-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inhaled nitroglycerin in people with COPD and COPD III/IV, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary functions (time frame: 5 days after start of nebulized nitroglycerin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06785337, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.