Albuterol for Bronchiolitis

Overseen By Andrea Rivera-Sepulveda, MD, MSc

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Nemours Children's Clinic

Must not be taking: Corticosteroids, Bronchodilators

Disqualifiers: Asthma, Chronic lung disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how well albuterol, a common asthma medication, works in children with bronchiolitis, a respiratory condition causing breathing problems. The goal is to determine if certain genetic factors enhance response to albuterol. Participants will receive either albuterol or a placebo in a randomized, controlled setting. Children visiting the emergency department with bronchiolitis symptoms, without other respiratory issues, may be eligible to join. This research could help doctors predict which children will benefit from albuterol, improving treatment strategies for bronchiolitis. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for bronchiolitis.

Will I have to stop taking my current medications?

The trial requires that participants do not use inhaled, nebulized, or oral corticosteroids within 72 hours before the emergency department visit and no bronchodilator use within 4 hours of arrival. If you are taking these medications, you may need to stop them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that albuterol is a well-known medication that helps open airways and is often used for asthma and similar breathing problems. For bronchiolitis, there is some debate about its effectiveness. However, safety information indicates it is generally safe when used for conditions like asthma.

One study found that both albuterol and epinephrine can be safely used in emergency rooms for treating infants with moderate bronchiolitis, suggesting that albuterol does not cause serious side effects in similar situations. While albuterol is safe, some health guidelines do not routinely recommend it for bronchiolitis due to ongoing debate about its effectiveness for this condition.

Overall, albuterol is widely used and considered safe based on its history of treating other breathing issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bronchiolitis?

Unlike the standard of care for bronchiolitis, which often involves supportive treatments like oxygen therapy and hydration, the use of albuterol in this context is unique because it acts as a bronchodilator. Albuterol specifically targets the muscles around the airways, helping them relax and widen, which can ease breathing in affected children. Researchers are excited about this treatment because, while albuterol is commonly used for asthma, its potential benefits for bronchiolitis are still being explored, offering a promising new option for managing symptoms in young patients.

What evidence suggests that albuterol might be an effective treatment for bronchiolitis?

Research has shown mixed results regarding albuterol's effectiveness in treating bronchiolitis in young children. Some studies suggest that albuterol can improve breathing and symptoms in children with this condition. However, other research indicates it doesn't significantly affect overall outcomes, such as hospital stay duration or long-term recovery. In this trial, participants will be randomized into different arms, with one group receiving albuterol and another receiving normal saline as a placebo comparator. These varied responses might result from genetic factors, which this study aims to explore. Albuterol is commonly used and considered safe, but its effectiveness for bronchiolitis remains uncertain. Understanding genetic influences may help identify which children might benefit more from this treatment. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 24 months who are presenting with bronchiolitis in the emergency department. The study aims to understand how these young patients respond to a common asthma medication, albuterol, based on their clinical symptoms and genetic makeup.

Inclusion Criteria

Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL)

My child is between 3 to 24 months old.

I have been diagnosed with bronchiolitis.

Exclusion Criteria

I took asthma medication by mouth or inhaler within 4 hours before coming to the ER.

Patients previously enrolled in the PI's K12 study

My pneumonia was confirmed by a chest X-ray.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of albuterol or placebo via nebulization, with patient information and respiratory assessment outcomes collected before and after intervention

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with genetic and clinical data collected to identify bronchodilator-responsive children

through study completion, an average of 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Albuterol

Trial Overview The trial tests whether a single dose of albuterol can improve breathing in infants with bronchiolitis compared to a placebo (saltwater solution). It's double-blind and randomized, meaning neither doctors nor participants know who gets the real medicine. Researchers will also look at genes that might predict who benefits from albuterol.

How Is the Trial Designed?

Group I: Bronchodilator arm Experimental Treatment 1 Intervention

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.

Group II: Normal saline arm Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Published Research Related to This Trial

A study of 130 treatment courses in 111 patients revealed that safety monitoring activities (SMAs) for EGFR and ALK inhibitors were inconsistently conducted, with prevalence ranging from 10.0% to 84.6%, and 31.5% of courses had no SMAs performed.

EGFR inhibitors were associated with a higher likelihood of SMAs being conducted compared to ALK inhibitors, highlighting the need for clinicians to closely follow FDA guidelines to ensure patient safety and monitor for serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring Activity During EGFR or Anaplastic Lymphoma Kinase Inhibitor Therapy for Patients With Lung Cancer. Singh, AM., Rubiera-Pebe, R., Ahmad, Y., et al.[2023]

A meta-analysis of 19 studies found that serious adverse events (SAEs) related to ALK inhibitors occurred in over 20% of patients, with ceritinib and brigatinib showing SAEs in more than 40% of participants, highlighting significant safety concerns.

Among the ALK inhibitors analyzed, alectinib was identified as the safest option, suggesting it may be preferable for patients due to its lower incidence of SAEs, particularly lung toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and serious adverse events of approved ALK inhibitors in malignancies: a meta-analysis. Hou, H., Sun, D., Liu, K., et al.[2020]

Interstitial lung disease (ILD) can be a serious side effect of oncological drugs, characterized by chronic lung inflammation and potential pulmonary fibrosis, highlighting the need for awareness among healthcare providers.

Prompt diagnosis and differentiation of drug-related pneumonia from other types of pneumonia are crucial for timely treatment adjustments, including stopping the offending drug and possibly starting immunosuppressive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Related Pneumonitis in Cancer Treatment during the COVID-19 Era. Cherri, S., Noventa, S., Fanelli, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7004745/

Efficacy of salbutamol in the treatment of infants with ... Based on the results of this systematic review, the use of salbutamol had no effect on bronchiolitis in children <24 months of age.

2. journals.lww.com journals.lww.com/md-journal/fulltext/2020/01240/efficacy_of_salbutamol_in_the_treatment_of_infants.14.aspx

Efficacy of salbutamol in the treatment of infants with... Our meta-analysis revealed that salbutamol can significantly increase the respiratory rate of infants with acute bronchiolitis after treatment compared with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022347605800514

Randomized trial of salbutamol in acute bronchiolitis Patients in the salbutamol arm had significantly greater improvement in clinical scores after the initial treatment (p=0.04). There was no difference between ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2019938/

Randomized trial of salbutamol in acute bronchiolitis We conclude that salbutamol is safe and effective for the initial treatment of young children with acute bronchiolitis.

5. publications.aap.org publications.aap.org/pediatrics/article/134/5/e1474/75848/Clinical-Practice-Guideline-The-Diagnosis

Clinical Practice Guideline: The Diagnosis, Management ... Two large, multicenter randomized trials comparing nebulized epinephrine to placebo65 or albuterol66 in the hospital setting found no improvement in LOS or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5942012/

Multicenter Study of Albuterol Use Among Infants ... The American Academy of Pediatrics currently recommends that inhaled albuterol not be used in routine care of children with bronchiolitis.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482272/

Albuterol - StatPearls - NCBI Bookshelf Albuterol is a commonly prescribed bronchodilator used for managing diverse respiratory conditions, including asthma and exercise-induced bronchospasm.

8. childrensmercy.org childrensmercy.org/siteassets/media-documents-for-depts-section/documents-for-health-care-providers/evidence-based-practice/critically-appraised-topics/bronchiolitis-albuterol-cat.pdf

Critically Appraised Topic (CAT): Bronchiolitis and ... Bronchodilator use for symptom management was addressed. The AAP strongly recommends against the use of albuterol (or salbutamol) in infants ...

9. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/485621

A Randomized Trial of Nebulized Epinephrine vs Albuterol ... Results of our study suggest that either epinephrine or albuterol may be used by ED physicians in the treatment of moderately ill infants with bronchiolitis.