CompletedPhase 4

Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

191 participantsStarted 2005-01

Plain-language summary

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Who can participate

Age range2 Years – 14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 2 and 14 years old * Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA) * Diagnosed with comorbid allergic rhinitis Exclusion Criteria: * Patients with suspected sinus infection * Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases

What they're measuring

Change From Baseline for Daytime Asthma Symptom Score

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT00442559

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10

Results submitted2008-10-12

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