Status:
COMPLETED
Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
Lead Sponsor:
Beyond Air Inc.
Conditions:
Bronchiolitis Acute
Eligibility:
All Genders
1-12 years
Phase:
PHASE2
Brief Summary
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis The proposed study judi...
Detailed Description
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis Bronchiolitis is a vira...
Eligibility Criteria
Inclusion
- Pediatric subjects up to 12-months of age, including subjects born ≥ 28 weeks of gestation.
- Subjects with acute bronchiolitis requiring in-patient hospitalization expected to last 24 hours or more.
- Modified Tal Score (mTal) between 7 to 10 at screening. Note that the oxygen requirement section of the clinical score reflects patient's oxygen saturation without oxygen supplementation.
- Screening SpO2 of 92% or less in room-air
- A parent/guardian who is willing to comply with the study procedures and signs an informed consent on behalf of the subject.
Exclusion
- Subjects diagnosed with alveolar pneumonia by chest X-ray and white blood cell (WBC)≥ 15,000/ul and Temp \>39°C
- Previous diagnosis of asthma or cough lasting more than 4 weeks or chronic requirement for asthma medications.
- Subjects with 2 or more previous physician diagnosed wheezing episodes.
- Any previous intensive care unit admission for respiratory distress or respiratory-related illness
- Diagnosis of Bronchopulmonary Dysplasia (BPD) based on medical history and home oxygen use.
- Subjects on home oxygen use for any reason
- Presence or use of a nasogastric or orogastric feeding tube
- Subjects with history of methemoglobinemia, known hereditary methemoglobinemia, and/or methemoglobin \>2% for any cause.
- Use of an investigational drug or device within 30 days before enrollment and/or expected to participate in a new study within 90 days of enrollment.
- History of frequent epistaxis (\>1 episode/month) or significant hemoptysis within 30 days prior to enrollment (≥5 mL of blood in one coughing episode)
- Taken medications such as chronic systemic corticosteroids, central nervous system (CNS) stimulants, theophylline or aminophylline, anti-arrhythmic within 30 days of screening.
- Diagnosed with an underlying condition, which significantly affects respiratory system:
- Cystic fibrosis (CF), primary ciliary dyskinesia, non-CF bronchiectasis
- Immune deficiency
- Genetic or neurological disorder capable of causing:
- Impaired respiratory secretions clearance including insufficient cough
- chronic respiratory failure and insufficiency
- restrictive lung disease
- Conditions that decrease the muscle strength
- Glucose 6-phosphate dehydrogenase deficiency
- 6-Phosphogluconate dehydrogenase deficiency
- Trisomy 21 (Down Syndrome)
- Presence of upper airway anomalies that may interfere with breathing, including:
- Choanal atresia or stenosis
- Cleft lip and palate
- Tracheo-esophageal fistula
- Tracheal stenosis
- Tracheomalacia and/or bronchomalacia
- History of severe aspiration pneumonia
- Having the following signs or symptoms:
- clinically significant pulmonary (lung) and/or cardiac (heart) congenital malformations
- an underlying renal, or liver insufficiency, immunodeficiency, encephalopathy;
- known or suspected foreign body aspiration during enrollment.
- If the first treatment cannot start within 6 hours after signing of the informed consent form (ICF), the subject is not eligible for enrollment.
- Symptoms (i.e., cough and wheezing) started longer than 72 h before admission to the hospital
- Per Investigator's discretion, the subject parents/legal guardian(s) are unable to comply with the study procedures.
- Any reason that, in the opinion of the investigator, may make the subject unfit for this clinical trial.
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2020
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04060979
Start Date
November 6 2019
End Date
April 2 2020
Last Update
May 12 2020
Active Locations (7)
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1
Haemek Medical Center
Afula, Israel
2
Assuta Ashdod
Ashdod, Israel
3
Soroka Medical Center
Beersheba, Israel
4
Carmel MEdical Center
Haifa, Israel