Related Experiment Video
Updated: May 5, 2026
Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
Published on: November 5, 2010
Long-term effects of budesonide or nedocromil in children with asthma
Insights
Inhaled budesonide and nedocromil did not improve lung function in children with asthma compared to placebo. However, budesonide enhanced airway responsiveness and asthma control, with minor growth effects.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Asthma Research
Background:
- Long-term efficacy of inhaled anti-inflammatory therapies for pediatric asthma remains under-researched.
- Current recommendations include inhaled corticosteroids and nedocromil for children with asthma.
Purpose of the Study:
- To evaluate the long-term effects of inhaled budesonide and nedocromil on lung function and asthma control in children.
- To compare the efficacy and safety of budesonide and nedocromil against placebo in pediatric asthma management.
Main Methods:
- A randomized trial involving 1041 children (5-12 years) with mild-to-moderate asthma.
- Participants received budesonide (200 mcg), nedocromil (8 mg), or placebo twice daily for 4-6 years.
- All children used albuterol as needed for symptom relief.
Main Results:
- No significant difference in the primary outcome (change in FEV1 post-bronchodilator) between treatments and placebo.
- Budesonide showed a smaller decline in FEV1:FVC ratio, improved airway responsiveness, and reduced hospitalizations and urgent visits compared to placebo.
- Nedocromil reduced urgent care visits and prednisone courses; budesonide showed a small, transient reduction in growth velocity.
Conclusions:
- Neither budesonide nor nedocromil improved lung function compared to placebo in children with mild-to-moderate asthma.
- Inhaled budesonide demonstrated superior asthma control and improved airway responsiveness over placebo and nedocromil.
- The primary side effect of budesonide was a minor, temporary decrease in growth velocity.
Background:
Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use.
Methods:
We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 microg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms.
Results:
There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups.
Conclusions:
In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity.
More Related Videos
Related Concept Videos
01:25Antiasthma Drugs: β2-Adrenoceptor Agonists
One class of bronchodilators includes β2-adrenoceptor agonists. These agents target the β2-adrenoceptors located on bronchial smooth muscle cells. By stimulating these receptors, β2-agonists induce...
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
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...
01:25Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...
01:26COPD: Management Using Bronchodilators and Corticosteroids
01:13Asthma III: Clinical Manifestations