COPDPhase 2NCT03873298
Inhaled NO in IPF and COPD During 6 Minute Walk Test
A Phase 2 study testing Inhaled nitric oxide in people with COPD and IPF, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Our objective is to evaluate the influence of inhaled NO on the saturation and exercise capacity of patients with COPD and IPF. each participant will undergo two six minute walk tests, one with inhaled NO and the other with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, IPF, Inhaled Nitric Oxide
- What is being tested?
- Inhaled nitric oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Mar 2019to 1 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients with COPD with disease severity of GOLD stage 3-4
- Patients with IPF with a Forced vital capacity under 80% and a diffusion capacity under 60%
- Ambulatory patients that can perform a 6-minute walk test
Who cannot join
- Patients with moderate to severe heart failure - EF < 40%
- Patients with severe PVD or scleroderma
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Mordechai R Kramer, MD
Mordechai R Kramer, MD
About this study
Official title: The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.
Our objective is to evaluate the influence of inhaled NO on the saturation and exercise capacity of patients with COPD and IPF. each participant will undergo two six minute walk tests, one with inhaled NO and the other with placebo.
Read the detailed description
This is a randomiized, placebo controlled trail that will evaluate the influence of inhaled NO (INO) on the saturation and exercise capacity of patients with COPD and IPF. All patients will sign a consent form before enrolment. Each patient will undergo two six-minute walk tests. Whether the INO will be used in the first or the second trial will be determined by computer generated randomization with random numbers sealed in opaque envelops. For the placebo 6-minute test we will use placebo cartridges in the INO generator, for INO 6-minute test we will use NO cartridges. The treatment with INO or placebo will start 20 minutes before the 6-minute walk test and will end at the end of the 6-minute walk test. Between tests a time interval of at least 60 minutes will be kept. During the test, the patients' pulse and saturation level will be monitored with a pulse oximetry. The data will be recorded continuously from baseline to 5 minutes after the test is over. The distance the patient walked will also be recorded. Patients that require supplemental oxygen will perform the tests with oxygen supplementation.
Dosing The NO dosing will be fixed. The first 10 patients will be treated with INO at a dose of 45 parts per million (ppm) per kilogram (kg). from patient 10 to 20 a dose of 75 ppm per kg will be given and from patient 20-100 a dose of 115 ppm per kg will be given.
- Conditions
- COPD, IPF, Inhaled Nitric Oxide, Six Minute Walk Test, Oxygen Saturation
- Being tested
- Inhaled nitric oxide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitric oxideDrug
Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | Each participant will undergo two six minute walk tests and the results will be compared within each subject. Receives: Drug: Inhaled nitric oxide |
| IPF | Experimental | Each participant will undergo two six minute walk tests and the results will be compared within each subject. Receives: Drug: Inhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saturation level during the test
AUC of the saturation value during six minute walk test
Measured: 26 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start4 Mar 2019
- Primary completion4 Mar 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT, placebo controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bellerophon
- Responsible party
- Principal investigator, Mordechai Kremer, Rabin Medical Center
- Investigators
- Mordechai Kramer, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873298
- Sponsor's protocol ID
- 0135-18-rmc
- Status last verified
- Dec 2019
- First submitted
- 11 Mar 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freidkin L, Kramer MR, Rosengarten D, Izhakian S, Taieb S, Pertzov B. The acute effect of inhaled nitric oxide on the exercise capacity of patients with advanced interstitial lung disease: a randomized controlled trial. BMC Pulm Med. 2024 May 10;24(1):226. doi: 10.1186/s12890-024-03051-4.
PubMed 38724947
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Inhaled Nitric Oxide on Oxygen Saturation of Patients With COPD and IPF During Six Minute Walk Test.
- ClinicalTrials.gov ID
- NCT03873298
- Acronym / sponsor ID
- 0135-18-rmc
- Conditions
- COPD, IPF, Inhaled Nitric Oxide, Six Minute Walk Test, Oxygen Saturation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Bellerophon
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 4 Mar 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 13 Mar 2019 (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.
Our objective is to evaluate the influence of inhaled NO on the saturation and exercise capacity of patients with COPD and IPF. each participant will undergo two six minute walk tests, one with inhaled NO and the other with placebo.
Detailed description
This is a randomiized, placebo controlled trail that will evaluate the influence of inhaled NO (INO) on the saturation and exercise capacity of patients with COPD and IPF. All patients will sign a consent form before enrolment. Each patient will undergo two six-minute walk tests. Whether the INO will be used in the first or the second trial will be determined by computer generated randomization with random numbers sealed in opaque envelops. For the placebo 6-minute test we will use placebo cartridges in the INO generator, for INO 6-minute test we will use NO cartridges. The treatment with INO or placebo will start 20 minutes before the 6-minute walk test and will end at the end of the 6-minute walk test. Between tests a time interval of at least 60 minutes will be kept. During the test, the patients' pulse and saturation level will be monitored with a pulse oximetry. The data will be recorded continuously from baseline to 5 minutes after the test is over. The distance the patient walked will also be recorded. Patients that require supplemental oxygen will perform the tests with oxygen supplementation.
Dosing The NO dosing will be fixed. The first 10 patients will be treated with INO at a dose of 45 parts per million (ppm) per kilogram (kg). from patient 10 to 20 a dose of 75 ppm per kg will be given and from patient 20-100 a dose of 115 ppm per kg will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Drug: Inhaled nitric oxideEach participant will undergo two six minute walk tests and the results will be compared within each subject. |
| IPF | Experimental | Drug: Inhaled nitric oxideEach participant will undergo two six minute walk tests and the results will be compared within each subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD with disease severity of GOLD stage 3-4
- Patients with IPF with a Forced vital capacity under 80% and a diffusion capacity under 60%
- Ambulatory patients that can perform a 6-minute walk test
Key exclusion criteria (2 listed)
- Patients with moderate to severe heart failure - EF < 40%
- Patients with severe PVD or scleroderma
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 nitric oxideInhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system | Drug | COPD, IPF |
Primary outcome
Saturation level during the test
Time frame: 26 minutes
AUC of the saturation value during six minute walk test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 38724947Freidkin L, Kramer MR, Rosengarten D, Izhakian S, Taieb S, Pertzov B. The acute effect of inhaled nitric oxide on the exercise capacity of patients with advanced interstitial lung disease: a randomized controlled trial. BMC Pulm Med. 2024 May 10;24(1):226. doi: 10.1186/s12890-024-03051-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mordechai Kramer, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled nitric oxide in people with COPD and IPF, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Dec 2019. 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 Israel. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barak Pertzov, MD (972548080196, pertzovb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saturation level during the test (time frame: 26 minutes). 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 NCT03873298, which also lists 1 linked publication.
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 26 Dec 2019.