Pulmonary FibrosisNCT05356052
Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis
A study testing INOpulse in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Bellerophon.
Trial summary
An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Pulmonary Hypertension
- What is being tested?
- INOpulse
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
- Subjects greater than 18 years of age at the time of consent to study participation.
- Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials.
- Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
- Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
- Subjects, in the opinion of the Investigator that would benefit from iNO treatment.
Who cannot join
- Subjects who require treatment with riociguat.
- Clinical contraindication to inhaled nitric oxide, as deemed by the Investigator.
- Subjects who require concurrent Positive Airway Pressure (PAP) or Positive End Expiratory Pressure (PEEP).
- Concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension
An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Being tested
- INOpulse
- Keywords
- PF, Pulmonary Fibrosis, Pulmonary Hypertension, PH, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, LTOT, Oxygen, INOpulse, pulsed inhaled nitric oxide, fILD, fibrotic interstitial lung disease, portable pulsed inhaled nitric oxide
- Medical subject headings
- Pulmonary Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOpulseCombination product
Patients will be treated by means of an INOpulse device using an INOpulse nasal cannula
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bellerophon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashika Ahmed, MD, Study director, Bellerophon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356052
- Sponsor's protocol ID
- PULSE-EAP-002
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05356052
- Acronym / sponsor ID
- PULSE-EAP-002
- Conditions
- Pulmonary Fibrosis, Pulmonary Hypertension
- Keywords
- PF, Pulmonary Fibrosis, Pulmonary Hypertension, PH, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, LTOT
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- BellerophonIndustry (pharma, biotech, devices)
- First posted
- 2 May 2022 (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.
An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
- Subjects greater than 18 years of age at the time of consent to study participation.
- Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials.
- Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
- Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
Key exclusion criteria (4 listed)
- Subjects who require treatment with riociguat.
- Clinical contraindication to inhaled nitric oxide, as deemed by the Investigator.
- Subjects who require concurrent Positive Airway Pressure (PAP) or Positive End Expiratory Pressure (PEEP).
- Concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.
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 |
|---|---|---|
| INOpulsePatients will be treated by means of an INOpulse device using an INOpulse nasal cannula | Combination product | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
Ashika Ahmed, MD study director
Bellerophon Therapeutics
Questions about this trial
What is this clinical trial studying?
A study testing INOpulse in people with Pulmonary Fibrosis and Pulmonary Hypertension, run by Bellerophon.
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 6 inclusion and 4 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Bobae Kim (917-675-2254, bobae.kim@bellerophon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 21 Feb 2023.