A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed iNO in Subjects With Pulmonary Fibrosis



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 85
Updated:1/12/2019
Start Date:December 29, 2017
End Date:June 2021
Contact:Deena Peace
Email:deena.peace@bellerophon.com
Phone:908-574-4847

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A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety and Efficacy of Pulsed iNO in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy

A phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to
assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in
subjects with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2).

A phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to
assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in
subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long
term oxygen therapy (Part 1 and Part 2).

Inclusion Criteria:

1. Signed Informed Consent

2. Diagnosed with pulmonary fibrosis by 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:

- Idiopathic pulmonary fibrosis

- Idiopathic nonspecific interstitial pneumonia

- Respiratory bronchiolitis-interstitial lung disease

- Desquamative interstitial pneumonia

- Cryptogenic organizing pneumonia

- Acute interstitial pneumonia

- Rare IIPs diagnosis by one of the following:

- Idiopathic lymphoid interstitial pneumonia

- Idiopathic pleuroparenchymal fibroelastosis

- Unclassifiable idiopathic interstitial pneumonias Chronic hypersensitivity
pneumonitis Occupational lung disease

3. At least 50% of the subjects will have confirmed intermediate or high probability of
pulmonary hypertension as determined by echocardiography according to the 2015 ESC/ERS
Guidelines for Diagnosis and Treatment of Pulmonary Hypertension.

4. Have been using oxygen therapy by nasal cannula for at least 4 weeks prior to the
screening run-in period.

5. 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization

6. WHO Functional Class II-IV

7. Forced Vital Capacity ≥ 40% predicted within last 6 months prior to screening the
screening run-in period.

8. For at least 1 week prior to Baseline/Randomization, subjects must demonstrate the
ability to consistently use the device greater than 12 hrs/day in the opinion of the
Investigator.

9. Female subjects of childbearing potential must have a negative pre-treatment pregnancy
test (serum or urine). All female subjects should take adequate precaution to avoid
pregnancy.

10. Subjects must have completed at least 1 week of activity monitoring prior to the
Baseline/Randomization visit.

11. Age between 18 and 85 years (inclusive)

12. Subject should be clinically stable for at least 4 weeks prior to
Baseline/Randomization in the opinion of the Principal Investigator.

Exclusion Criteria:

1. Demonstrate symptomatic rebound defined as significant cardiopulmonary instability,
such as systemic arterial oxygen desaturation, hypoxemia, bradycardia, tachycardia,
systemic hypotension, shortness of breath, near-syncope, and syncope, occurring within
1 hour of acute iNO during rebound testing

2. Episodes of disease worsening within 1 month prior to Baseline/Randomization

3. Use of any PAH-specific medications regardless of reason for use

4. Acute or chronic physical impairment (other than dyspnea due to PF) that would limit
the ability to comply with study procedures or adherence to therapy (i.e., 6MWT),
including carrying and wearing the pulsed delivery device per study protocol, or
medical problem(s) likely to preclude completion of the study

5. Pregnant or breastfeeding females at Screening

6. Administered L-arginine within 1 month prior to Screening

7. The concurrent use of the INOpulse device with a continuous positive airway pressure
(CPAP), Bilevel positive airway pressure (BPAP), or any other positive pressure
device.

8. Use of investigational drugs or devices within 1 month prior to Screening (other than
acute vasodilator testing with iNO)

9. Any underlying medical or psychiatric condition that, in the opinion of the
Investigator, makes the subject an unsuitable candidate for the study including unable
to complete 6MWT.

10. Any subject who has been enrolled in any previous clinical study with inhaled NO
administered through pulse delivery

11. In the last 6 months prior to screening, evidence of any connective tissue disease
with FVC > 60% unless there is evidence of moderate to severe fibrosis on CT scan in
the opinion of the Investigator

12. Evidence of clinically significant Combined Pulmonary Fibrosis and Emphysema (CPFE) if
> 15% of lung fields by CT scan show evidence of emphysema in the opinion of the
Investigator
We found this trial at
20
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Sonja Bartolome, MD
Phone: 214-645-6493
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Srihari Veeraraghavan, MD
Phone: 404-727-2011
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Roger Alvarez, MD
Phone: 305-243-9383
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: James Loyd, MD
Phone: 615-343-7068
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Syed Mobin, MD
Phone: 407-841-1100
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Elizabeth Belloli, MD
Phone: 734-936-8301
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Aurora, Colorado 80046
Principal Investigator: Todd Bull, MD
Phone: 303-724-7938
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Austell, Georgia 30106
Principal Investigator: Amy Case, MD
Phone: 770-745-1404
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Rahul Argula, MD
Phone: 843-792-3169
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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232 South Woods Mill Road
Chesterfield, Missouri 63017
Principal Investigator: Neil A Ettinger, MD, FACCP
Phone: 314-682-3653
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Chicago, Illinois 60153
Phone: 708-216-5744
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Nishant Gupta, MD
Phone: 513-558-0027
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Amy Olson, MD
Phone: 303-270-2622
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Falls Church, Virginia 22042
Principal Investigator: Christopher King, MD
Phone: 703-776-6147
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Louisville, Kentucky 40202
Principal Investigator: John McConnell, MD
Phone: 502-587-8000
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Jeffrey Stewart, MD
Phone: 215-707-4260
Temple University Temple University is many things to many people. A place to pursue life's...
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Phoenix, Arizona 85013
Principal Investigator: Jeremy Feldman, MD
Phone: 602-271-0832
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Richmond, Virginia 23225
Principal Investigator: Shilpa Johri, MD
Phone: 804-288-5945
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2315 Stockton Boulevard
Sacramento, California 95817
Principal Investigator: Roblee Allen, MD
Phone: 916-734-1554
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Salt Lake City, Utah 84132
Principal Investigator: MaryBeth Scholand, MD
Phone: 801-581-5811
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