BronchiolitisPhase 3NCT06946264
Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
A Phase 3 study testing Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution and Sodium Chloride 0.9% Inhl 3Ml in people with Bronchiolitis and Bronchodilator Agents, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in bronchiolitis remains controversial due to the heterogeneity in patient response. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Bronchiolitis, Bronchodilator Agents
- What is being tested?
- Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution and Sodium Chloride 0.9% Inhl 3Ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2022to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 3 to 24 months of age
- Clinical diagnosis of bronchiolitis by the treating provider(s), defined by the American Academy of Pediatrics as a clinical syndrome involving lower respiratory tract symptoms
- Children who either have no history of prematurity or have a history of prematurity but without associated co-morbidities
- Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL)
Who cannot join
- Patients previously enrolled in the PI's K12 study
- Documented history of asthma or reactive airway disease
- Co-morbidities affecting airway response (e.g., chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease, immunodeficiency, neurologic condition)
- Diagnosis of pneumonia by chest radiography
- Inhaled, nebulized, or oral corticosteroid use within 72 hours of ED evaluation
- Inhaled, nebulized, or oral bronchodilator administration within 4 hours of ED arrival
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Health
Orlando, Florida, 32827
About this study
Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in bronchiolitis remains controversial due to the heterogeneity in patient response. Although studies indicate that bronchodilators do not enhance outcomes in bronchiolitis, meta-analyses can obscure the heterogeneity of treatment effects. While bronchodilator response genetics have not been explored in bronchiolitis, treatment effectiveness variations often depend on genomic factors. Genome-wide association studies (GWAS) have linked genetic variants with bronchodilator response and outcomes in childhood asthma, suggesting a bronchodilator-responsive genotype. This proposal aims to extend this paradigm to bronchiolitis, addressing the gap in knowledge where GWAS and clinical characteristics intersect. The proposed study's objective is to characterize phenotypic and genotypic variations of children with bronchiolitis and their association with bronchodilator response. We hypothesize that children with bronchiolitis who exhibit clinical and historical characteristics associated with atopy and specific physical findings have genetic variants linked to bronchodilator response. To achieve this, we propose to (Aim 1) define airway responsiveness to bronchodilator treatment in children with bronchiolitis using the change in respiratory score, (Aim 2a) identify the associations between candidate genetic variants and bronchodilator response among children with bronchiolitis, and (Aim 2b) determine the associations between candidate genetic variants and clinical patient data to identify bronchodilator-responsive children with bronchiolitis. A prospective, double-blind, randomized, placebo-controlled trial of a single albuterol dose in children aged 3 to 24 months presenting with bronchiolitis to the emergency department will be conducted to achieve these aims. Patient information and respiratory assessment outcomes will be collected before and after intervention. Blood, urine, DNA buccal swabs, and nasopharyngeal swabs will also be collected. Completion of these aims will result in a novel clinical prediction model for bronchodilator response determination in bronchiolitis, integrating clinical, physical, and genetic data. Furthermore, this research supports the candidates' career development goals of advancing training in clinical trial research design and execution and becoming an expert in clinical and translational methods to enhance pediatric emergency department health and outcomes. Ultimately, this work will inform an R01 application to validate an evidence-based prediction rule for identifying bronchodilator-responsive children with bronchiolitis through a multi-center emergency medicine research network, optimizing therapeutic approaches, and reducing resource use in those with a low likelihood of bronchodilator response.
- Conditions
- Bronchiolitis, Bronchodilator Agents
- Being tested
- Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Sodium Chloride 0.9% Inhl 3Ml
- Keywords
- double-blind randomized clinical trial
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation SolutionDrug
Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (albuterol sulfate 2.5mg/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis.
Sodium Chloride 0.9% Inhl 3MlDrug
Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (sodium chloride 0.9% 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis.
| Study group | Role | What they receive |
|---|---|---|
| Bronchodilator arm | Experimental | Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (albuterol sulfate 2.5mg/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis. Receives: Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution |
| Normal saline arm | Placebo comparator | Children with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (sodium chloride 0.9%/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis. Receives: Drug: Sodium Chloride 0.9% Inhl 3Ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Clinically Important Difference (Aim 1)
Identify the minimum clinically important difference (MCID) in the modified Tal score (MTS) in children with bronchiolitis from parents/ caregivers and treating providers' perceived improvement in respiratory response. The minimum clinically important difference (MCID) is a 15-point scale, ranging from -7 (very much worse) to +7 (very much improved), as assessed by responses from the caregiver(s) and the treating provider(s). A response of +1 to +2 will be interpreted as a "small" perceived improvement in respiratory function.
The modified Tal score (MTS) includes respiratory parameters documented as part of the ED standard of care. The MTS score ranges from 0 to 12 points, with higher scores indicating greater respiratory distress.
Measured: Immediately after the intervention
Candidate genetic variants (Aim 2)
Identify candidate single nucleotide polymorphisms (SNPs), rank-ordered by the strength of their association with the modified Tal score (delta) respiratory score based on an odds ratio (dichotomous response) or a beta coefficient (continuous response) and filtered by adjusted p-value.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start8 Jul 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Rivera-Sepulveda, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946264
- Sponsor's protocol ID
- 1866573
- Status last verified
- May 2026
- First submitted
- 11 Apr 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data that will be preserved and shared are demographical data, history of prematurity, immunizations, history of corticosteroid use, past medical history, family history, environmental exposure, pulmonary history, randomized drug administered, and physical exam data, among other data pertinent to the study. Clinical data from data collection forms will be preserved and shared. Genomic data that will be preserved and shared will include variant calls from genotyping microarrays with imputation. Clinical data sets will be submitted to the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in .CSV format. Genomic data sets will be submitted to the Database of Genotypes and Phenotypes (dbGaP, NCBI, NIH) in CRAM, and VCF format.
Publications
McCulloh RJ, Smitherman SE, Koehn KL, Alverson BK. Assessing the impact of national guidelines on the management of children hospitalized for acute bronchiolitis. Pediatr Pulmonol. 2014 Jul;49(7):688-94. doi: 10.1002/ppul.22835. Epub 2013 Jul 19.
PubMed 23868897Knapp JF, Simon SD, Sharma V. Variation and trends in ED use of radiographs for asthma, bronchiolitis, and croup in children. Pediatrics. 2013 Aug;132(2):245-52. doi: 10.1542/peds.2012-2830. Epub 2013 Jul 22.
PubMed 23878045Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001 Oct;108(4):851-5. doi: 10.1542/peds.108.4.851.
PubMed 11581435Gong C, Byczkowski T, McAneney C, Goyal MK, Florin TA. Emergency Department Management of Bronchiolitis in the United States. Pediatr Emerg Care. 2019 May;35(5):323-329. doi: 10.1097/PEC.0000000000001145.
PubMed 28441240Viswanathan M, King VJ, Bordley C, Honeycutt AA, Wittenborn J, Jackman AM, Sutton SF, Lohr KN. Management of bronchiolitis in infants and children. Evid Rep Technol Assess (Summ). 2003 Jan;(69):1-5. No abstract available.
PubMed 12624885Gadomski AM, Scribani MB. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD001266. doi: 10.1002/14651858.CD001266.pub4.
PubMed 24937099Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
PubMed 25349312Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.
PubMed 17142527Hasegawa K, Tsugawa Y, Brown DF, Mansbach JM, Camargo CA Jr. Trends in bronchiolitis hospitalizations in the United States, 2000-2009. Pediatrics. 2013 Jul;132(1):28-36. doi: 10.1542/peds.2012-3877. Epub 2013 Jun 3.
PubMed 23733801Willer RJ, Coon ER, Harrison WN, Ralston SL. Trends in Hospital Costs and Levels of Services Provided for Children With Bronchiolitis Treated in Children's Hospitals. JAMA Netw Open. 2021 Oct 1;4(10):e2129920. doi: 10.1001/jamanetworkopen.2021.29920.
PubMed 34698848Keren R, Luan X, Localio R, Hall M, McLeod L, Dai D, Srivastava R; Pediatric Research in Inpatient Settings (PRIS) Network. Prioritization of comparative effectiveness research topics in hospital pediatrics. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1155-64. doi: 10.1001/archpediatrics.2012.1266.
PubMed 23027409Meissner HC. Viral Bronchiolitis in Children. N Engl J Med. 2016 Jan 7;374(1):62-72. doi: 10.1056/NEJMra1413456. No abstract available.
PubMed 26735994Fujiogi M, Goto T, Yasunaga H, Fujishiro J, Mansbach JM, Camargo CA Jr, Hasegawa K. Trends in Bronchiolitis Hospitalizations in the United States: 2000-2016. Pediatrics. 2019 Dec;144(6):e20192614. doi: 10.1542/peds.2019-2614. Epub 2019 Nov 7.
PubMed 31699829
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features
- ClinicalTrials.gov ID
- NCT06946264
- Acronym / sponsor ID
- 1866573
- Conditions
- Bronchiolitis, Bronchodilator Agents
- Keywords
- double-blind randomized clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Apr 2025 (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.
Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in bronchiolitis remains controversial due to the heterogeneity in patient response. Although studies indicate that bronchodilators do not enhance outcomes in bronchiolitis, meta-analyses can obscure the heterogeneity of treatment effects. While bronchodilator response genetics have not been explored in bronchiolitis, treatment effectiveness variations often depend on genomic factors. Genome-wide association studies (GWAS) have linked genetic variants with bronchodilator response and outcomes in childhood asthma, suggesting a bronchodilator-responsive genotype. This proposal aims to extend this paradigm to bronchiolitis, addressing the gap in knowledge where GWAS and clinical characteristics intersect. The proposed study's objective is to characterize phenotypic and genotypic variations of children with bronchiolitis and their association with bronchodilator response. We hypothesize that children with bronchiolitis who exhibit clinical and historical characteristics associated with atopy and specific physical findings have genetic variants linked to bronchodilator response. To achieve this, we propose to (Aim 1) define airway responsiveness to bronchodilator treatment in children with bronchiolitis using the change in respiratory score, (Aim 2a) identify the associations between candidate genetic variants and bronchodilator response among children with bronchiolitis, and (Aim 2b) determine the associations between candidate genetic variants and clinical patient data to identify bronchodilator-responsive children with bronchiolitis. A prospective, double-blind, randomized, placebo-controlled trial of a single albuterol dose in children aged 3 to 24 months presenting with bronchiolitis to the emergency department will be conducted to achieve these aims. Patient information and respiratory assessment outcomes will be collected before and after intervention. Blood, urine, DNA buccal swabs, and nasopharyngeal swabs will also be collected. Completion of these aims will result in a novel clinical prediction model for bronchodilator response determination in bronchiolitis, integrating clinical, physical, and genetic data. Furthermore, this research supports the candidates' career development goals of advancing training in clinical trial research design and execution and becoming an expert in clinical and translational methods to enhance pediatric emergency department health and outcomes. Ultimately, this work will inform an R01 application to validate an evidence-based prediction rule for identifying bronchodilator-responsive children with bronchiolitis through a multi-center emergency medicine research network, optimizing therapeutic approaches, and reducing resource use in those with a low likelihood of bronchodilator response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchodilator arm | Experimental | Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation SolutionChildren with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (albuterol sulfate 2.5mg/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis. |
| Normal saline arm | Placebo comparator | Drug: Sodium Chloride 0.9% Inhl 3MlChildren with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (sodium chloride 0.9%/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis. |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between 3 to 24 months of age
- Clinical diagnosis of bronchiolitis by the treating provider(s), defined by the American Academy of Pediatrics as a clinical syndrome involving lower respiratory tract symptoms
- Children who either have no history of prematurity or have a history of prematurity but without associated co-morbidities
- Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL)
Key exclusion criteria (6 listed)
- Patients previously enrolled in the PI's K12 study
- Documented history of asthma or reactive airway disease
- Co-morbidities affecting airway response (e.g., chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease, immunodeficiency, neurologic condition)
- Diagnosis of pneumonia by chest radiography
- Inhaled, nebulized, or oral corticosteroid use within 72 hours of ED evaluation
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 |
|---|---|---|
| Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation SolutionChildren with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (albuterol sulfate 2.5mg/ 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis. | Drug | Bronchodilator arm |
| Sodium Chloride 0.9% Inhl 3MlChildren with bronchiolitis will be randomized to an intervention arm to be administered as a nebulization (sodium chloride 0.9% 3mL inhalation solution). The intervention drug will be placed in a sealed manila envelope, randomized in advance by a Nemours Investigational Drug Pharmacist, and stored in the ED pyxis. | Drug | Normal saline arm |
Primary outcome
Minimum Clinically Important Difference (Aim 1)
Time frame: Immediately after the intervention
Identify the minimum clinically important difference (MCID) in the modified Tal score (MTS) in children with bronchiolitis from parents/ caregivers and treating providers' perceived improvement in respiratory response. The minimum clinically important difference (MCID) is a 15-point scale, ranging from -7 (very much worse) to +7 (very much improved), as assessed by responses from the caregiver(s) and the treating provider(s). A response of +1 to +2 will be interpreted as a "small" perceived improvement in respiratory function. The modified Tal score (MTS) includes respiratory parameters documented as part of the ED standard of care. The MTS score ranges from 0 to 12 points, with higher scores indicating greater respiratory distress.
Candidate genetic variants (Aim 2)
Time frame: through study completion, an average of 1 year
Identify candidate single nucleotide polymorphisms (SNPs), rank-ordered by the strength of their association with the modified Tal score (delta) respiratory score based on an odds ratio (dichotomous response) or a beta coefficient (continuous response) and filtered by adjusted p-value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 23868897McCulloh RJ, Smitherman SE, Koehn KL, Alverson BK. Assessing the impact of national guidelines on the management of children hospitalized for acute bronchiolitis. Pediatr Pulmonol. 2014 Jul;49(7):688-94. doi: 10.1002/ppul.22835. Epub 2013 Jul 19.
- Background: PubMed 23878045Knapp JF, Simon SD, Sharma V. Variation and trends in ED use of radiographs for asthma, bronchiolitis, and croup in children. Pediatrics. 2013 Aug;132(2):245-52. doi: 10.1542/peds.2012-2830. Epub 2013 Jul 22.
- Background: PubMed 11581435Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001 Oct;108(4):851-5. doi: 10.1542/peds.108.4.851.
- Background: PubMed 28441240Gong C, Byczkowski T, McAneney C, Goyal MK, Florin TA. Emergency Department Management of Bronchiolitis in the United States. Pediatr Emerg Care. 2019 May;35(5):323-329. doi: 10.1097/PEC.0000000000001145.
- Background: PubMed 12624885Viswanathan M, King VJ, Bordley C, Honeycutt AA, Wittenborn J, Jackman AM, Sutton SF, Lohr KN. Management of bronchiolitis in infants and children. Evid Rep Technol Assess (Summ). 2003 Jan;(69):1-5. No abstract available.
- Background: PubMed 24937099Gadomski AM, Scribani MB. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD001266. doi: 10.1002/14651858.CD001266.pub4.
- Background: PubMed 25349312Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
- Background: PubMed 17142527Pelletier AJ, Mansbach JM, Camargo CA Jr. Direct medical costs of bronchiolitis hospitalizations in the United States. Pediatrics. 2006 Dec;118(6):2418-23. doi: 10.1542/peds.2006-1193.
- Background: PubMed 23733801Hasegawa K, Tsugawa Y, Brown DF, Mansbach JM, Camargo CA Jr. Trends in bronchiolitis hospitalizations in the United States, 2000-2009. Pediatrics. 2013 Jul;132(1):28-36. doi: 10.1542/peds.2012-3877. Epub 2013 Jun 3.
- Background: PubMed 34698848Willer RJ, Coon ER, Harrison WN, Ralston SL. Trends in Hospital Costs and Levels of Services Provided for Children With Bronchiolitis Treated in Children's Hospitals. JAMA Netw Open. 2021 Oct 1;4(10):e2129920. doi: 10.1001/jamanetworkopen.2021.29920.
- Background: PubMed 23027409Keren R, Luan X, Localio R, Hall M, McLeod L, Dai D, Srivastava R; Pediatric Research in Inpatient Settings (PRIS) Network. Prioritization of comparative effectiveness research topics in hospital pediatrics. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1155-64. doi: 10.1001/archpediatrics.2012.1266.
- Background: PubMed 26735994Meissner HC. Viral Bronchiolitis in Children. N Engl J Med. 2016 Jan 7;374(1):62-72. doi: 10.1056/NEJMra1413456. No abstract available.
- Individual participant dataSharing planned: Yes. Clinical data that will be preserved and shared are demographical data, history of prematurity, immunizations, history of corticosteroid use, past medical history, family history, environmental exposure, pulmonary history, randomized drug administered, and physical exam data, among other data pertinent to the study. Clinical data from data collection forms will be preserved and shared. Genomic data that will be preserved and shared will include variant calls from genotyping microarrays with imputation. Clinical data sets will be submitted to the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in .CSV format. Genomic data sets will be submitted to the Database of Genotypes and Phenotypes (dbGaP, NCBI, NIH) in CRAM, and VCF format.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution and Sodium Chloride 0.9% Inhl 3Ml in people with Bronchiolitis and Bronchodilator Agents, run by Nemours Children's Clinic at 1 site in United States.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 United States. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Rivera-Sepulveda, MD, MSc (407-489-6847, andrea.rivera-sepulveda@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Clinically Important Difference (Aim 1) (time frame: Immediately after the intervention). 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?
On the ClinicalTrials.gov record for NCT06946264, which also lists 13 linked publications.
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 8 May 2026.