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- || INOpulse (nitric oxide) / Bellerophon Therap
Clinical, Journal: Inhaled Nitric Oxide in Fibrotic Lung Disease: A Randomized, Double-Blind, Placebo-Controlled Trial. (Pubmed Central) - Nov 27, 2024
P3
There was no demonstrable benefit to iNO in patients with f-ILD on supplemental oxygen in daily physical activity assessed by actigraphy, a potential novel clinical trial endpoint. Clinical trial registration available at www.
- INOpulse (nitric oxide) / Bellerophon Therap
Inhaled Nitric Oxide in Fibrotic Lung Disease: A Randomized, Double-blind, Placebo-controlled Trial (San Diego Convention Center, Ballroom 20A (Upper Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_7134;
There was no demonstrable benefit to inhaled nitric oxide in patients with fibrotic interstitial lung disease on supplemental oxygen. The therapy was safe and well-tolerated while the study affirmed the feasibility of actigraphy as a clinical trial endpoint.
- ||||||| INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial termination: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Jul 28, 2023
P3, N=145, Terminated, Sponsor: Bellerophon Pulse Technologies
The therapy was safe and well-tolerated while the study affirmed the feasibility of actigraphy as a clinical trial endpoint. Trial completion date: Sep 2024 --> Jun 2023 | Active, not recruiting --> Terminated; The trial did not meet its primary endpoint, hence was terminated due to futility.
- | INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH (clinicaltrials.gov) - Feb 21, 2023
P3, N=22, Active, not recruiting, Sponsor: Bellerophon Pulse Technologies
Trial completion date: Sep 2024 --> Jun 2023 | Active, not recruiting --> Terminated; The trial did not meet its primary endpoint, hence was terminated due to futility. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
- |||| INOpulse (nitric oxide) / Bellerophon Therap
Enrollment closed: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Jan 20, 2023
P3, N=145, Active, not recruiting, Sponsor: Bellerophon Pulse Technologies
Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 Recruiting --> Active, not recruiting
- ||||| INOpulse (nitric oxide) / Bellerophon Therap
Enrollment change: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Dec 5, 2022
P3, N=140, Recruiting, Sponsor: Bellerophon Pulse Technologies
Recruiting --> Active, not recruiting N=300 --> 140
- |||| INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Oct 21, 2022
P3, N=300, Recruiting, Sponsor: Bellerophon Pulse Technologies
N=300 --> 140 Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2022 --> Sep 2023
- || INOpulse (nitric oxide) / Bellerophon Therap
Trial completion, Trial completion date: A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis (clinicaltrials.gov) - Aug 10, 2022
P2, N=17, Completed, Sponsor: Bellerophon
Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2022 --> Sep 2023 Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Jun 2022
- |||||| INOpulse (nitric oxide) / Bellerophon Therap
New trial: PULSE-EAP-002: Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis (clinicaltrials.gov) - May 1, 2022
P=N/A, N=0, Available, Sponsor: Bellerophon
- || INOpulse (nitric oxide) / Bellerophon Therap
Clinical, P2 data, Journal: A Phase-2 Exploratory Randomized Controlled Trial of INOpulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen. (Pubmed Central) - Apr 6, 2022
P3
Further validation of this beneficial effect warrants further study in a phase 3 trial that is currently underway. Clinical Trial Registration with ClinicalTrials.gov: NCT03267108 Primary Source of Funding: Bellerophon Therapeutics.
- INOpulse (nitric oxide) / Bellerophon Therap
A Phase 2 Trial of INOpulse in Patients with Sarcoidosis Associated Pulmonary Hypertension (SAPH) Requiring Supplemental Oxygen (Room 9-10 (South Building, Exhibition Level), Moscone Center) - Mar 23, 2022 - Abstract #ATS2022ATS_6911;
INOpulse was well tolerated and associated with clinically meaningful reductions in mean pulmonary artery pressure and pulmonary vascular resistance. The results support the continued development of iNO as a potential treatment option for patients with sarcoidosis complicated by PH.
- | INOpulse (nitric oxide) / Bellerophon Therap
Enrollment closed, Trial completion date, Trial primary completion date: A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis (clinicaltrials.gov) - Feb 8, 2022
P2, N=17, Active, not recruiting, Sponsor: Bellerophon
The results support the continued development of iNO as a potential treatment option for patients with sarcoidosis complicated by PH. Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Mar 2022 | Trial primary completion date: Jun 2021 --> Sep 2021
- ||| INOpulse (nitric oxide) / Bellerophon Therap
So why did Nitric oxide fail for Bellerophon therapeutics? @RogerAlvarezDO @fabten (Twitter) - Sep 5, 2021
- ||| INOpulse (nitric oxide) / Bellerophon Therap, Enovid (nitric oxide nasal spray) / SaNOtize
Dr. Alvarez, why did inopulse fail for Covid, but @SanotizeD 's Enovid NO spray seems to work? (Twitter) - Sep 5, 2021
- |||| INOpulse (nitric oxide) / Bellerophon Therap
Phase classification, Trial completion date, Trial primary completion date: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Aug 2, 2021
P3, N=300, Recruiting, Sponsor: Bellerophon Pulse Technologies
Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Mar 2022 | Trial primary completion date: Jun 2021 --> Sep 2021 Phase classification: P2/3 --> P3 | Trial completion date: Oct 2022 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Dec 2022
- | INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH (clinicaltrials.gov) - Jul 21, 2021
P3, N=22, Active, not recruiting, Sponsor: Bellerophon Pulse Technologies
Phase classification: P2/3 --> P3 | Trial completion date: Oct 2022 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Dec 2022 Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022
- || INOpulse (nitric oxide) / Bellerophon Therap
Clinical, Journal: A Randomized, double-blind, placebo-controlled study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) at a dose of 30 mcg/kg-IBW/hr (iNO 30) in subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) receiving Oxygen Therapy. (Pubmed Central) - May 26, 2021
iNO 30 demonstrated clinically and statistically significant benefit in MVPA and clinically significant benefit in overall activity. In the OLE, higher doses of iNO were also safe and well tolerated while showing maintenance in activity parameters.
- || INOpulse (nitric oxide) / Bellerophon Therap
How's your Inopulse study recruiting going? (Twitter) - May 15, 2021
- | INOpulse (nitric oxide) / Bellerophon Therap
Trial primary completion date: A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis (clinicaltrials.gov) - May 6, 2021
P2, N=16, Recruiting, Sponsor: Bellerophon
In the OLE, higher doses of iNO were also safe and well tolerated while showing maintenance in activity parameters. Trial primary completion date: Feb 2021 --> Jun 2021
- | INOpulse (nitric oxide) / Bellerophon Therap
Enrollment change, Trial completion date, Trial termination: COViNOX: A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (clinicaltrials.gov) - Apr 28, 2021
P3, N=191, Terminated, Sponsor: Bellerophon Pulse Technologies
Trial primary completion date: Feb 2021 --> Jun 2021 N=500 --> 191 | Trial completion date: Jun 2021 --> Jan 2021 | Active, not recruiting --> Terminated; Futility
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Clinical: Let us know how your Inopulse is doing to save Covid patients. Who is stopping you to talk about it? Is it FDA or some other entity? (Twitter) - Mar 8, 2021
- | INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis (clinicaltrials.gov) - Jan 12, 2021
P2, N=16, Recruiting, Sponsor: Bellerophon
N=500 --> 191 | Trial completion date: Jun 2021 --> Jan 2021 | Active, not recruiting --> Terminated; Futility Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Nov 2020 --> Feb 2021
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Clinical: Why are all the ER doctors who were treating Covid patients via Inopulse are quiet? Are these doctors been paid by someone to be silent and let the patients die now? 24 out of 25 Covid patients were treated via INOPULSE successfuly by you 🙏 @Wassim_FaresMD @fabten @SteveFDA (Twitter) - Jan 8, 2021
- |||| INOpulse (nitric oxide) / Bellerophon Therap
Clinical: Why you all are not using #inopulse from Bellerophon Therapeutics to save Covid patients that needs oxygen to survive? Too much greed in this country and just focusing on Vaccines and no focus on therapeutics. ☹️🙏 (Twitter) - Dec 28, 2020
- ||||| INOpulse (nitric oxide) / Bellerophon Therap
Enrollment closed: COViNOX: A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (clinicaltrials.gov) - Nov 30, 2020
P3, N=500, Active, not recruiting, Sponsor: Bellerophon Pulse Technologies
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Nov 2020 --> Feb 2021 Recruiting --> Active, not recruiting
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Money will not save your lives. It's all on God's will. Be human and save innocent humans. Please save lives by approving #Inopulse from Bellerophon Therapeutics for Covid treatment. @SteveFDA @CDCDirector @Surgeon_General @NIHDirector @ChrisCuomo @innovationwonk @washingtonpost (Twitter) - Nov 18, 2020
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Do something good for Americans. Bring Inopulse from Bellerophon Therapeutics for Covid treatment. We need to save lives. God bless everyone! @ChrisCuomo @ashishkjha @drsanjaygupta @washingtonpost @JoeBiden @BillGates @NIHDirector @SteveFDA @CDCDirector (Twitter) - Nov 8, 2020
- |||||| INOpulse (nitric oxide) / Bellerophon Therap
Enrollment open: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Nov 6, 2020
P2/3, N=300, Recruiting, Sponsor: Bellerophon Pulse Technologies
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Oct 7, 2020
P2/3, N=300, Active, not recruiting, Sponsor: Bellerophon Pulse Technologies
Active, not recruiting --> Recruiting Trial completion date: Mar 2023 --> Oct 2022
- ||| INOpulse (nitric oxide) / Bellerophon Therap
@CDCDirector I hope you bring out Inopulse from Bellerophon Therapeutics ASAP to save the American lives affected by Covid. 🙏 (Twitter) - Oct 5, 2020
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Shame on all who are not bringing out #inopulse for treatment of Covid. God is watching and people who are dead because of Covid will get the justice soon. Karma will prevail. @SteveFDA @realDonaldTrump @fabten @innovationwonk @BARDA @CDCDirector @NIHDirector (Twitter) - Sep 24, 2020
- ||||| INOpulse (nitric oxide) / Bellerophon Therap
Clinical: Those poor pregnant women need Nitric Oxide inhalation therapy that is very safe and can also be given to new borns. Support #Inopulse from Bellerophon Therapeutics an American company ready to save lives from #COVID19 if given opportunity and funding. @BARDA (Twitter) - Sep 16, 2020
- | INOpulse (nitric oxide) / Bellerophon Therap
Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date: NO-COVER: iNOPulse for COVID-19 (clinicaltrials.gov) - Aug 19, 2020
P2, N=0, Withdrawn, Sponsor: Roger Alvarez
Trial completion date: Mar 2023 --> Oct 2022 N=30 --> 0 | Trial completion date: Jan 2021 --> Jul 2021 | Initiation date: Jul 2020 --> Dec 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jan 2021 --> Jun 2021
- ||| INOpulse (nitric oxide) / Bellerophon Therap
@BARDA @realDonaldTrump @BillGates @innovationwonk @US_FDA - SUPPORT Bellerophon #inopulse to beat #COVID19 and bring America back again. 🙏 (Twitter) - Aug 18, 2020
- | INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis (clinicaltrials.gov) - Jul 20, 2020
P2, N=16, Recruiting, Sponsor: Bellerophon
N=30 --> 0 | Trial completion date: Jan 2021 --> Jul 2021 | Initiation date: Jul 2020 --> Dec 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jan 2021 --> Jun 2021 Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Nov 2020
- |||||| INOpulse (nitric oxide) / Bellerophon Therap
Enrollment open: COViNOX: A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (clinicaltrials.gov) - Jul 13, 2020
P3, N=500, Recruiting, Sponsor: Bellerophon Pulse Technologies
Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Nov 2020 Not yet recruiting --> Recruiting
- INOpulse (nitric oxide) / Bellerophon Therap
[VIRTUAL] An Acute Dose Escalation Study to Assess the Safety and Hemodynamic Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis (PF) or Sarcoidosis (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_4692;
Conclusion In the first 3 subjects with pulmonary fibrosis undergoing a RHC assessing the dose response to iNO delivered by the iNOpulse device, we observed a clinically meaningful improvement in hemodynamics. All subjects tolerated the doses well, with no change in oxygen saturation suggesting ventilation perfusion is maintained.
- INOpulse (nitric oxide) / Bellerophon Therap
[VIRTUAL] Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension (PH) Associated with Fibrotic Interstitial Lung Disease (fILD) on Long Term Oxygen Therapy (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_278;
The benefit in the objective measurement of activity tracked that observed with the two PROs. iNOpulse is planned to be studied in a Phase 3 placebo-controlled registrational study in patients with fILD.
- |||| INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: COViNOX: A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (clinicaltrials.gov) - Jul 5, 2020
P3, N=500, Not yet recruiting, Sponsor: Bellerophon Pulse Technologies
iNOpulse is planned to be studied in a Phase 3 placebo-controlled registrational study in patients with fILD. Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Nov 2020 --> Feb 2021
- ||| INOpulse (nitric oxide) / Bellerophon Therap
Clinical: I am very happy to hear that you are doing study on Covid patients with Inopulse and hope you get good results. This could be a game changer for the whole world. Do you have any expected completion date for that study? Thanks. (Twitter) - Jun 25, 2020
- ||||| INOpulse (nitric oxide) / Bellerophon Therap
Phase classification, Enrollment change, Trial completion date, Trial primary completion date: REBUILD: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (clinicaltrials.gov) - Jun 16, 2020
P2/3, N=300, Active, not recruiting, Sponsor: Bellerophon Pulse Technologies
Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Nov 2020 --> Feb 2021 Phase classification: P2 --> P2/3 | N=80 --> 300 | Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: Nov 2021 --> Jun 2022
- |||||||||| INOpulse (nitric oxide) / Bellerophon Therap
New P3 trial: COViNOX: A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19 (clinicaltrials.gov) - Jun 8, 2020
P3, N=500, Not yet recruiting, Sponsor: Bellerophon Pulse Technologies
- | INOpulse (nitric oxide) / Bellerophon Therap
New P2 trial: NO-COVER: iNOPulse for COVID-19 (clinicaltrials.gov) - May 21, 2020
P2, N=30, Not yet recruiting, Sponsor: Roger Alvarez
- || remdesivir (GS-5734) / Gilead, Actemra IV (tocilizumab) / Roche, JW Pharma
I would start someone on INOpulse and them remdesivir If they worsen. Then tocilizumab if they worsen further. (Twitter) - Apr 29, 2020
- ||| remdesivir (GS-5734) / Gilead, Actemra IV (tocilizumab) / Roche, JW Pharma
Clinical: start patients on INOpulse nitric oxide and remdesivir before critical!--if they worsen, start on tocilizumab (Twitter) - Apr 29, 2020
- | INOpulse (nitric oxide) / Bellerophon Therap
Trial completion date, Trial primary completion date: A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis (clinicaltrials.gov) - Apr 24, 2020
P2, N=16, Recruiting, Sponsor: Bellerophon
Phase classification: P2 --> P2/3 | N=80 --> 300 | Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: Nov 2021 --> Jun 2022 Trial completion date: Apr 2020 --> Jul 2020 | Trial primary completion date: Mar 2020 --> Jun 2020
- |||||| INOpulse (nitric oxide) / Bellerophon Therap
New trial: Pulsed Inhaled Nitric Oxide for the Treatment of Patients With Mild or Moderate COVID-19 (clinicaltrials.gov) - Apr 23, 2020
P, N=0, Available, Sponsor: Bellerophon
- | $BLPH FDA Grants Bellerophon Emergency Expanded Access for INOpulse for the Treatment of #COVID19 Virus (Twitter) - Mar 20, 2020
- An Acute Dose Escalation Study to Assess the Safety and Hemodynamic Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis (PF) or Sarcoidosis (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area D) - Mar 15, 2020 - Abstract #ATS2020ATS_7192;
All subjects tolerated the iNO doses well with no evidence of oxygen desaturation.ConclusionIn the first 3 subjects with pulmonary fibrosis undergoing a RHC assessing the dose response to iNO delivered by the iNOpulse device, we observed a clinically meaningful improvement in hemodynamics. All subjects tolerated the doses well, with no change in oxygen saturation suggesting ventilation perfusion is maintained.
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension (PH) Associated with Fibrotic Interstitial Lung Disease (fILD) on Long Term Oxygen Therapy (PENNSYLVANIA CONVENTION CENTER, Terrace Ballroom II (Terrace Ballroom Level)) - Mar 15, 2020 - Abstract #ATS2020ATS_2940;
The benefit in the objective measurement of activity tracked that observed with the two PROs. iNOpulse is planned to be studied in a Phase 3 placebo-controlled registrational study in patients with fILD.