At a glance
ClinicalIndex Comparison Record- ✓Age 5 to 12 years at screening
- ✓Chronic asthma with evidence of symptoms ≥2x/week or ≥2 bronchodilator uses per week or daily asthma medication for ≥6 months in past year
- ✓Current asthma symptoms (diary code ≥1 or morning/evening PEFR <80% post-bronchodilator) on ≥8 days during screening
- ✓Methacholine sensitivity with PC20 FEV1 ≤12.5 mg/ml
- ✕Any other active pulmonary disease
- ✕Chronic condition interfering with trial completion or confounding results
- ✕Pulmonary function findings suggesting ventilatory defect other than asthma or irreversible lung damage
- ✕Severe chronic sinusitis or nasal polyposis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Childhood Asthma Management Program
In Brief
A Phase 3 clinical trial evaluating Placebo, Nedocromil, and 1 other intervention for Asthma and Lung Diseases. Completed, enrolled 1,041 participants.
Detailed Summary
The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
Study Details
Timeline
Interventions
Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn OR four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.
Four 2 mg puffs bid + two 90 Og puffs albuterol prn
Two 100 Og puffs bid + two 90 Og puffs albuterol prn.