Related Experiment Video
Updated: Dec 6, 2025
Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
Published on: April 6, 2017
Randomized pilot trial of ipratropium versus placebo in children with critical asthma
Kaitlyn Murphy1, Nabihah Mahmood1, Daniel Craven2
1Division of Pediatric Critical Care Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.
Insights
Inhaled ipratropium did not improve clinical outcomes for critically ill children with severe asthma. This study found no significant difference in albuterol duration or hospital stay when comparing ipratropium to placebo.
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Severe asthma exacerbations in children require intensive management.
- Albuterol is a standard treatment, but adjunctive therapies are explored for critical cases.
- Ipratropium bromide is a bronchodilator with potential benefits in severe airway obstruction.
Purpose of the Study:
- To evaluate the efficacy of inhaled ipratropium bromide as an adjunctive therapy in critically ill children with severe asthma.
- To determine if ipratropium reduces the duration of high-intensity albuterol treatment and intensive care unit (ICU) or hospital length of stay.
Main Methods:
- A pilot, placebo-controlled, double-blinded, randomized controlled trial was conducted.
- Thirty children with critical asthma were randomized to receive either nebulized ipratropium (500 µg) or placebo every 6 hours.
- Treatment continued until patients could be weaned to albuterol every 2 hours, with outcomes including duration of high-intensity albuterol, ICU, and hospital length of stay.
Main Results:
- No significant difference was observed in the median duration of high-intensity albuterol between the ipratropium group (17.5 hours) and the placebo group (14.6 days).
- There were no statistically significant differences in pediatric intensive care unit length of stay (22.6 vs. 21.4 hours) or hospital length of stay (48.0 vs. 47.3 hours).
- Multivariate regression analysis confirmed no significant association between ipratropium treatment and the studied clinical outcomes. Side effects were rare and similar between groups.
Conclusions:
- Adjunctive inhaled ipratropium therapy did not demonstrate a significant benefit in reducing the duration of high-intensity albuterol treatment or shortening hospital stays in critically ill children with severe asthma.
- The findings suggest that ipratropium may not be an effective adjunctive treatment for this patient population.
- Larger, multicenter trials are recommended to definitively confirm these results and explore potential benefits in specific subgroups or with different treatment protocols.
Objective:
To test the effects of inhaled ipratropium on clinical outcomes of critical asthma in the first randomized trial of this adjunctive therapy in critically ill children.
Design:
Pilot, placebo-controlled, double-blinded, and randomized-controlled trial PATIENTS: Thirty children (15 per group) with critical asthma receiving high-intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration.
Interventions:
Subjects were randomized to receive either nebulized ipratropium bromide (500 µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline every 6 h until the patient was successfully weaned to albuterol doses every 2 h ("q2 albuterol").
Measurements And Main Results:
Demographics, initial clinical severity score, and asthma histories were similar between groups. There was no significant difference in the median duration of high-intensity albuterol between the treatment group (17.5 [10.3-22.1] h) and placebo group (14.6 [12.7-24.5] days; p = .56). Similarly, there was no significant difference in pediatric intensive care unit length of stay (22.6 [21.1-33.6] vs. 21.4 [16.1-35.8] h; p = .74) or hospital length of stay (48.0 [41.8-59.8] vs. 47.3 [37.2-63.1] h; p = .67). In multivariate linear regression adjusting for identified confounders, treatment with ipratropium was not significantly associated with any of the three outcomes. Side effects were rare and occurred with equally between both groups CONCLUSIONS: Adjunctive therapy with ipratropium was not associated with decreased duration of high-intensity albuterol or shortened length of stay when compared to placebo. A larger, multicenter trial is warranted to confirm that ipratropium does not improve clinical outcomes.
Related Concept Videos
01:30Asthma-IV: Diagnostic and Management
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
01:23Inhaled Medications
01:20Antiasthma Drugs: Muscarinic Receptor Antagonists
Antimuscarinic agents compete with ACh for the same binding site on the muscarinic receptors. By binding to these receptors, they inhibit the downstream effects of ACh and block the parasympathetic...
01:13Randomized Experiments
Simple randomization
Simple...
01:25Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
01:24Asthma-III: Symptoms and Complications
Classification of Asthma