Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

Exercise Induced Asthma Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127166
• Other study ID #: 0476-911
• Secondary ID: 2004_006
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced
• Exercise Induced Asthma

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)