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Vasodilator
INOpulse for Pulmonary Hypertension with Pulmonary Fibrosis
Phase 2
Waitlist Available
Research Sponsored by Bellerophon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8 or 16
Awards & highlights
Summary
This trial studies the safety and effectiveness of a drug to help with breathing problems in people with pulmonary fibrosis using oxygen therapy.
Eligible Conditions
- Pulmonary Fibrosis
- Pulmonary Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 8 or 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8 or 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
Other study objectives
Adverse events that may be due to rebound associated with a temporal acute withdrawal of investigational study drug
Change in 6-minute walking test (6MWT) from baseline
Change in Forced Expiratory Volume at 1 minute (FEV1)
+13 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Long Term Follow UpActive Control1 Intervention
Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr
Group II: Inhaled Nitric Oxide (iNO)Active Control1 Intervention
Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr)
Group III: PlaceboPlacebo Group1 Intervention
Pulsed inhaled N2, 99.999% gas
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Who is running the clinical trial?
BellerophonLead Sponsor
7 Previous Clinical Trials
142 Total Patients Enrolled
3 Trials studying Pulmonary Fibrosis
25 Patients Enrolled for Pulmonary Fibrosis
Ashika Ahmed, MDStudy DirectorBellerophon Therapeutics
10 Previous Clinical Trials
969 Total Patients Enrolled
1 Trials studying Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with World Health Organization (WHO) Functional Class II-IV.In the last 6 months before the screening, you have a connective tissue disease that affects your lungs, unless a CT scan shows moderate to severe fibrosis.Your lung function was measured and it needs to be at least 40% of what is expected for someone your age and size.You must be between 18 and 85 years old.You have been diagnosed with pulmonary fibrosis within the last 6 months using specific guidelines and tests.You have been using a nasal cannula for oxygen therapy for at least 4 weeks.You need to be able to walk between 100 and 450 meters in six minutes during screening and baseline visits.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Long Term Follow Up
- Group 3: Inhaled Nitric Oxide (iNO)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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