BronchiolitisPhase 1/2NCT01768884
Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis
A Phase 1/2 study testing Nitric Oxide in people with Bronchiolitis, run by Beyond Air Inc. at 1 site in Israel.
Trial summary
Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa Bronchiolitis is defined as an infection of the small airways. Read more about this study
- Who is it for?
- Ages 2 months to 1 year
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects (Male or female) 2-12 months old
- Diagnosed as bronchiolitis
- Parents/ legal guardian signed informed consent.
Who cannot join
- Subjects diagnosed with concomitant diseases such as pneumonia,urine tract infection (UTI) or otitis media
- Prematurity <36 weeks gestational age.
- Received (Respiratory syncytial virus) RSV immunoglobulin prophylaxis
- Subjects diagnosed with, methemoglobinemia, chronic lung disease, immune deficiency, heart disease
- Use of an investigational drug within 30 days before enrollment and not expected to participate in a new study within 30 days
- History of frequent epistaxis (>1 episode/month)
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- Significant hemoptysis within 30 days (≥ 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period)
- Methemoglobin >3% at screening
- Subjects cannot fulfill the study design
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- Underlying diseases such as genetic disorders (Cystic fibrosis, Down Syndrome) or chronic lung diseases (Bronchopulmonary dysplasia,Primary ciliary dyskinesia, Bronchiolitis Obliterans), hypotonia, Congenital heart disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa Prospective, Double Blind, Randomized Single-Center, Evaluation of the Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis
Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa Bronchiolitis is defined as an infection of the small airways. It is also the most common manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the leading cause of global child mortality. NO has been shown to play a critical role in various biological functions, including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and immune responses to infection such as microbicidal action directed toward various organisms. NO in the airways is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built.
It has shown the beneficial effect of NO in different diseases with several options of doses and regimens - from newborn with primary pulmonary hypertension which showed improvement in oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at 18 and 36 ppm.
Read more
In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a wide variety of phyla including bacteria, viruses, helminthes and parasites.
Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO intermittent inhalation treatment compared to standard treatment in 2-12 months old bronchiolitis subjects.
Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2 -12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition to standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the standard treatment for 5 days.
Treatment administration: Treatment blindness will be kept by separating between unblinded team members (giving the actual treatment) and blinded team members, and by hiding the NO container and all study related equipment behind a curtain. Between study inhalations the subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO , nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be continuously monitored.
All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted on day 30 (+5) from day of admission to the department.
End of study treatment (both groups) will be assessed by a blinded study physician base on clinical assessment. Subject improvement that will lead to end study treatment = clinical score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from the hospital.
- Conditions
- Bronchiolitis
- Being tested
- Nitric Oxide, Placebo
- Keywords
- Infants, Bronchiolitis, NO, inhalation
- Medical subject headings
- Bronchiolitis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Nitric oxide inhalation + standard treatment | Experimental | Inhalation of 160 ppm gNO for 30 minutes, 5 times daily, for 5 consecutive days or until discharged, which occurs first. Receives: Drug: Nitric Oxide |
| Standard treatment | Placebo comparator | Standard treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Met-Hemoglobin percentage (MetHb) associated with inhaled NO
Measured: 21 days
Number of participants with adverse events associated with inhaled NO as a measure of safety and tolerability
Measured: 5 days
Secondary outcomes (1)
Proportion of subjects (%) who prematurely discontinued the study due to adverse events (AEs)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Soroka University Medical Center
- Responsible party
- Sponsor
- Investigators
- Asher Tal, M.D, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768884
- Sponsor's protocol ID
- AIT_CP_BRONC01.01
- Status last verified
- May 2016
- First submitted
- 14 Jan 2013
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Prospective, Double Blind, Randomized Single-Center, Evaluation of the Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis
- ClinicalTrials.gov ID
- NCT01768884
- Acronym / sponsor ID
- AIT_CP_BRONC01.01
- Conditions
- Bronchiolitis
- Keywords
- Infants, Bronchiolitis, NO, inhalation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Collaborators
- Soroka University Medical Center
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa Bronchiolitis is defined as an infection of the small airways. It is also the most common manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the leading cause of global child mortality. NO has been shown to play a critical role in various biological functions, including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and immune responses to infection such as microbicidal action directed toward various organisms. NO in the airways is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built.
It has shown the beneficial effect of NO in different diseases with several options of doses and regimens - from newborn with primary pulmonary hypertension which showed improvement in oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at 18 and 36 ppm.
In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a wide variety of phyla including bacteria, viruses, helminthes and parasites.
Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO intermittent inhalation treatment compared to standard treatment in 2-12 months old bronchiolitis subjects.
Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2 -12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition to standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the standard treatment for 5 days.
Treatment administration: Treatment blindness will be kept by separating between unblinded team members (giving the actual treatment) and blinded team members, and by hiding the NO container and all study related equipment behind a curtain. Between study inhalations the subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO , nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be continuously monitored.
All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted on day 30 (+5) from day of admission to the department.
End of study treatment (both groups) will be assessed by a blinded study physician base on clinical assessment. Subject improvement that will lead to end study treatment = clinical score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitric oxide inhalation + standard treatment | Experimental | Drug: Nitric OxideInhalation of 160 ppm gNO for 30 minutes, 5 times daily, for 5 consecutive days or until discharged, which occurs first. |
| Standard treatment | Placebo comparator | Drug: PlaceboStandard treatment |
Who may qualify
- Ages
- 2 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects (Male or female) 2-12 months old
- Diagnosed as bronchiolitis
- Parents/ legal guardian signed informed consent.
Key exclusion criteria (11 listed)
- Subjects diagnosed with concomitant diseases such as pneumonia,urine tract infection (UTI) or otitis media
- Prematurity <36 weeks gestational age.
- Received (Respiratory syncytial virus) RSV immunoglobulin prophylaxis
- Subjects diagnosed with, methemoglobinemia, chronic lung disease, immune deficiency, heart disease
- Use of an investigational drug within 30 days before enrollment and not expected to participate in a new study within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric Oxide | Drug | Nitric oxide inhalation + standard treatment |
| Placebo | Drug | Standard treatment |
Primary outcome
Met-Hemoglobin percentage (MetHb) associated with inhaled NO
Time frame: 21 days
Number of participants with adverse events associated with inhaled NO as a measure of safety and tolerability
Time frame: 5 days
1 secondary outcome
Proportion of subjects (%) who prematurely discontinued the study due to adverse events (AEs)
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher Tal, M.D principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide in people with Bronchiolitis, run by Beyond Air Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Met-Hemoglobin percentage (MetHb) associated with inhaled NO (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.