Bronchiolitis AcutePhase 2NCT04060979
Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
A Phase 2 study testing Nitric Oxide and Standard Supportive treatment in people with Bronchiolitis Acute, run by Beyond Air Inc. at 7 sites in Israel.
Trial 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 judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Bronchiolitis Acute
- What is being tested?
- Nitric Oxide and Standard Supportive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 7 sitesIsrael
- Study dates
- 6 Nov 2019to 2 Apr 2020
- Phase
- Phase 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 37Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
Haemek Medical Center
Afula
Assuta Ashdod
Ashdod
Soroka Medical Center
Beersheba
Carmel MEdical Center
Haifa
Shaarei Zedek Medical Center
Jerusalem
Schneider Children's hospital
Petah Tikva
Sheba Medical Center
Tel HaShomer
About this study
Official title: Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
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 judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
Read more
Primary objective:
- Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis, compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
Read the 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 viral disease, widely spread amongst young children with significant mortality in some cases and no specific treatment available, besides supportive treatment of O2 and hydration; therefore, there is an identified unmet medical need to develop a treatment strategy for children with bronchiolitis.
When the immune system's NO generating ability is overwhelmed or compromised, infection and disease occur. Increasing the body's ability to produce more NO through gene therapy or synthetic NO donor drugs is of interest in medicine.
NO, by itself, is an essential part of the innate defense mechanism of the human immune system which becomes up-regulated by the inducible NO synthase (iNOS) during various inflammatory conditions and during microbial and viral infections. This suggests that NO treatment in appropriate concentrations is highly relevant for children with bronchiolitis.
The two previous pilot studies conducted by Beyond Air (formerly known as AIT) found that intermittent exposure to was safe and well tolerated in pediatric subjects with acute bronchiolitis age 0-12 months and showed a trend in reduction in the length of hospitalization. The overall frequency of adverse events was found to be similar between the control and NO treated groups and intermittent exposure at 160 ppm did not result in exposure to unsafe Nitric Dioxide (NO2) levels or had a cumulative effect on MetHb levels.
The proposed study judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
NO therapy can be cost effective, technologically simple and easily adaptive for use in inhaled pulmonary infections. Ultimately, therapeutic use of NO could be the initial treatment by mimicking the body's natural first line method to fight infections. Together, these results and rationale warrant the need to accelerate research of NO as a potential solution for front line treatment for bronchiolitis.
Primary objective:
- Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis, compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
- Conditions
- Bronchiolitis Acute
- Being tested
- Nitric Oxide, Standard Supportive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Nitric Oxide given intermittently via inhalation
Standard Supportive treatmentOther
Standard Supportive treatment (including oxygen)
| Study group | Role | What they receive |
|---|---|---|
| Group 1- NO treatment- dose 1 | Experimental | Will comprise of approximately 30 patients and will receive inhalations of dose 1 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. Receives: Drug: Nitric Oxide; Other: Standard Supportive treatment |
| Group 2- NO treatment- dose 2 | Experimental | Will comprise of approximately 30 patients and will receive inhalations of dose 2 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. Receives: Drug: Nitric Oxide; Other: Standard Supportive treatment |
| Group 3- Control treatment | Other | Will comprise of approximately 30 patients and will receive O2/air using the same treatment schedule and equipment as groups 1 and 2, in addition to standard supportive treatment. Receives: Other: Standard Supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to "fit for discharge"
Time to "fit for discharge". "Fit for discharge" is a composite endpoint measured by the following:
- Achieving Modified Tal score [mTal] ≤ 5 And
- Oxygen saturation (SpO2) ≥92% at room air (without oxygen supplementation) sustained for at least 2 hours Both of these will be determined from the time of enrollment (when the ICF is signed).
Measured: up to 14 days
Secondary outcomes (4)
Time to achieve O2 saturation of ≥ 92 %. sustained for at least 2 hours
The time in hours calculated from the time of patient's enrollment until the time required to achieve the endpoint.
Measured: up to 14 days
Hospital Length of Stay (LOS)
LOS is measured in hours from the time of patient's enrollment in the study until the physician's order to discharge from the hospital. A patient will be evaluated for discharge from the hospital only after meeting the primary efficacy endpoint.
Measured: up to 14 days
Modified Tal score [mTal] ≤5
The time in hours calculated from the time of patient's enrollment until the time required to achieve a clinical score of less than or equal to 5.
Measured: up to 14 days
Incidence of Treatment-Emergent Adverse Events
Number of treatment-emergent adverse events (AEs) and Serious AEs
Measured: Baseline to 30 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start6 Nov 2019
- Primary completion2 Mar 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis AcuteStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aviv Goldbart, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060979
- Sponsor's protocol ID
- AIT_CP_BRONC_03.01
- Status last verified
- Jan 2020
- First submitted
- 11 Aug 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldbart A, Lavie M, Lubetzky R, Pillar G, Landau D, Schlesinger Y, Spiegel R, Golan-Tripto I, Nahum A, Greenberg D, Tal A. Inhaled Nitric Oxide for the Treatment of Acute Bronchiolitis: A Multicenter Randomized Controlled Clinical Trial to Evaluate Dose Response. Ann Am Thorac Soc. 2023 Feb;20(2):236-244. doi: 10.1513/AnnalsATS.202103-348OC.
PubMed 36169967
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
- ClinicalTrials.gov ID
- NCT04060979
- Acronym / sponsor ID
- AIT_CP_BRONC_03.01
- Conditions
- Bronchiolitis Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- 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-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 judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
Primary objective:
- Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis, compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
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 viral disease, widely spread amongst young children with significant mortality in some cases and no specific treatment available, besides supportive treatment of O2 and hydration; therefore, there is an identified unmet medical need to develop a treatment strategy for children with bronchiolitis.
When the immune system's NO generating ability is overwhelmed or compromised, infection and disease occur. Increasing the body's ability to produce more NO through gene therapy or synthetic NO donor drugs is of interest in medicine.
NO, by itself, is an essential part of the innate defense mechanism of the human immune system which becomes up-regulated by the inducible NO synthase (iNOS) during various inflammatory conditions and during microbial and viral infections. This suggests that NO treatment in appropriate concentrations is highly relevant for children with bronchiolitis.
The two previous pilot studies conducted by Beyond Air (formerly known as AIT) found that intermittent exposure to was safe and well tolerated in pediatric subjects with acute bronchiolitis age 0-12 months and showed a trend in reduction in the length of hospitalization. The overall frequency of adverse events was found to be similar between the control and NO treated groups and intermittent exposure at 160 ppm did not result in exposure to unsafe Nitric Dioxide (NO2) levels or had a cumulative effect on MetHb levels.
The proposed study judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
NO therapy can be cost effective, technologically simple and easily adaptive for use in inhaled pulmonary infections. Ultimately, therapeutic use of NO could be the initial treatment by mimicking the body's natural first line method to fight infections. Together, these results and rationale warrant the need to accelerate research of NO as a potential solution for front line treatment for bronchiolitis.
Primary objective:
- Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis, compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1- NO treatment- dose 1 | Experimental | Drug: Nitric Oxide, Other: Standard Supportive treatmentWill comprise of approximately 30 patients and will receive inhalations of dose 1 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. |
| Group 2- NO treatment- dose 2 | Experimental | Drug: Nitric Oxide, Other: Standard Supportive treatmentWill comprise of approximately 30 patients and will receive inhalations of dose 2 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. |
| Group 3- Control treatment | Other | Other: Standard Supportive treatmentWill comprise of approximately 30 patients and will receive O2/air using the same treatment schedule and equipment as groups 1 and 2, in addition to standard supportive treatment. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (37 listed)
- 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.
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 OxideNitric Oxide given intermittently via inhalation | Drug | Group 1- NO treatment- dose 1, Group 2- NO treatment- dose 2 |
| Standard Supportive treatmentStandard Supportive treatment (including oxygen) | Other | Group 1- NO treatment- dose 1, Group 2- NO treatment- dose 2, Group 3- Control treatment |
Primary outcome
Time to "fit for discharge"
Time frame: up to 14 days
Time to "fit for discharge". "Fit for discharge" is a composite endpoint measured by the following: * Achieving Modified Tal score [mTal] ≤ 5 And * Oxygen saturation (SpO2) ≥92% at room air (without oxygen supplementation) sustained for at least 2 hours Both of these will be determined from the time of enrollment (when the ICF is signed).
4 secondary outcomes
Time to achieve O2 saturation of ≥ 92 %. sustained for at least 2 hours
Time frame: up to 14 days
Hospital Length of Stay (LOS)
Time frame: up to 14 days
Modified Tal score [mTal] ≤5
Time frame: up to 14 days
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 30 days post dose
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 12 May 2020.
- Derived from this study: PubMed 36169967Goldbart A, Lavie M, Lubetzky R, Pillar G, Landau D, Schlesinger Y, Spiegel R, Golan-Tripto I, Nahum A, Greenberg D, Tal A. Inhaled Nitric Oxide for the Treatment of Acute Bronchiolitis: A Multicenter Randomized Controlled Clinical Trial to Evaluate Dose Response. Ann Am Thorac Soc. 2023 Feb;20(2):236-244. doi: 10.1513/AnnalsATS.202103-348OC.
- Individual participant dataSharing planned: No
Related trials for Bronchiolitis Acute
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Recruiting
Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease
RecruitingPhase 1
A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children
GVHD (Acute or Chronic)
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.
Aviv Goldbart principal investigator
Soroka University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide and Standard Supportive treatment in people with Bronchiolitis Acute, run by Beyond Air Inc. at 7 sites 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 5 inclusion and 37 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Time to "fit for discharge" (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04060979, which also lists 1 linked publication.
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 12 May 2020.