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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00127166
Other study ID # 0476-911
Secondary ID 2004_006
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2005
Est. completion date November 2008

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria: - 6-14 year old children with a history of asthma for at least 12 months - must demonstrate airway constriction brought on by exercise Exclusion Criteria: - is taking any medications that are not allowed in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Montelukast sodium
Montelukast 5 mg chewable tablet once daily
Salmeterol xinafoate
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Fluticasone propionate
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Montelukast matching placebo
Matching placebo to montelukast oral tablet administered once daily.
Salmeterol matching placebo
Matching placebo to salmeterol dry powder for inhalation administered twice daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Post-exercise Percent (%) Fall in FEV1 The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1. 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Secondary Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline. 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Secondary Maximum FEV1 % Predicted Following First Beta-agonist Use The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting ß-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first ß-agonist use. 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Secondary Time to Recovery to Within 5% of Baseline FEV1 The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge. 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Secondary Average (Avg) %-Change in FEV1 After First Beta (ß)-Agonist Use and Prior to Second ß-agonist Use The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first ß-agonist intake and prior to second ß-agonist use. 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
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