Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

Asthma Clinical Trial

Official title:

A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289874
• Other study ID #: 0476-336
• Secondary ID: 2006_001
• Status: Completed
• Phase: Phase 3
• Start date: March 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season

• Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

• Patient cannot have any other acute or chronic pulmonary disorder

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast sodium
montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
• Comparator: Placebo
Placebo. Up to 3 weeks of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20. doi: 10.1080/02770900902847727. Erratum in: J Asthma. 2009 Oct;46(8):858. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3	Percent change from baseline in FEV1, a measure of airway function, at Week 3	Baseline and week 3
Secondary	Percent Change From Baseline in Mean Daily "as Needed" ß-agonist Use Over the 3-week Treatment Period	Percent change from baseline in average daily ß-agonist use over the 3-week treatment period	Baseline and Week 3