Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

PHASE3CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

April 30, 2001

Primary Completion Date

October 31, 2001

Study Completion Date

November 30, 2001

Conditions
Asthma
Interventions
DRUG

montelukast sodium

Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks

DRUG

Comparator: Usual Care

Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00943397 - Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232) | Biotech Hunter | Biotech Hunter