A Phase 3 interventional study of INOpulse® and Placebo in Pulmonary Fibrosis and Pulmonary Hypertension, sponsored by Bellerophon Pulse Technologies. Terminated at 64 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Bellerophon Pulse Technologies · Phase 3, Interventional, and Treatment
Among 128 studies in Pulmonary Fibrosis with a site in United States — 30 open to participants now, 42 under way, 5 of them phase 3. Pulmonary Fibrosis · United States.
Among the 128 studies in Pulmonary Fibrosis with a site in United States, this one is the 26th largest by enrollment of the 90 interventional ones that give a count, is one of 9 that started in 2020, is one of 15 in phase 3, and was the 69th registered.
342 studies on the registry are indexed under Pulmonary Fibrosis; 98 are open to participants now.
Browse Pulmonary Fibrosis studies →30 of the 128 studies in Pulmonary Fibrosis with a site in United States are open now. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Ages 18+
PureTech · Sites in United States, Canada
Ages 40+
Peter Caravan · Sites in United States
Ages 18–80
University of Wisconsin, Madison · Sites in United States
Ages 18+
Cedars-Sinai Medical Center · Sites in United States
Ages 50+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 71 Pulmonary Fibrosis studies recruiting now, 41 (58%) set no upper age limit and 4 (6%) stop at 75 or younger; 8 take children under 18; 12 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
128 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 48 · Phase 3 17 · Phase 4 3
First in 1978; this study’s year is marked. 9 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 145 is above the median of 59 across 212 interventional studies indexed under Pulmonary Fibrosis.
Median enrollment 50 across the 90 interventional studies, 200 across the 37 observational. Of the 76 that completed or were terminated, 37 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
45 of 128 have an industry lead sponsor. The 10 most frequent:
Bellerophon Pulse Technologies is the lead sponsor of 7 studies on the registry; none are open to participants now.
Bellerophon Pulse Technologies has 1 study filed under Pulmonary Fibrosis — fewer than ten, so there is no comparison to draw.
9 of the studies in Pulmonary Fibrosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04948203Phase 3University of ChicagoAssessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis | 2026-12 |
| NCT00515567University of ChicagoExplanted Lung Tissues With Pulmonary Fibrosis | 2026-12 |
| NCT06567717Cedars-Sinai Medical CenterZinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis | 2027-01 |
| NCT04964115Vanderbilt University Medical CenterPost Acute Sequelae of COVID-19 | 2027-05-31 |
| NCT06329401Avalyn Pharma Inc.A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis | 2027-06 |
Add all 9 to your calendar (.ics) → With an account.
Among the 128 studies in Pulmonary Fibrosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using guidelines, as per American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following:
Rare IIPs diagnosis by one of the following:
Unclassifiable idiopathic interstitial pneumonias
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pulsed inhaled iNO 45 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Combination Product: INOpulse®
Pulsed inhaled N2, 99.999% gas
Combination Product: Placebo
Pulsed inhaled iNO 45 mcg/kg IBW/hr
Combination Product: Open Label Extension
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
Part 1 - Blinded Treatment Period
Time frame: Baseline to Month 4
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy
Part 2 - Open Label Extension (OLE)
Time frame: Baseline to Month 4
Change in Overall Activity as Measured by Actigraphy
Part 1 - Blinded Treatment Period
Time frame: Baseline to M4
Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
Part 1 Blinded Treatment Period: The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).
Time frame: Baseline to Month 4
Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total
Part 1 Blinded Treatment Period: SGRQ is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)
Time frame: Baseline to Month 4
Time to Clinical Worsening
Part 1 - Blinded Treatment Period
Time frame: Baseline to Month 4
Time to Clinical Deterioration
Part 1 Blinded Treatment Period
Time frame: Baseline to Month 4
Time to Clinical Improvement
Part 1 Blinded Treatment Period
Time frame: Baseline to Month 4
Change in 6 Minute Walk Distance
Part 1 Blinded Treatment Period
Time frame: Baseline to Month 4
Plan to share: No
Ran from Dec 2020 to primary completion in Jun 2023, 29 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitric Oxide
Bellerophon Pulse Technologies