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Salmeterol xinafoate

Phase 3

Exercise Induced Asthma | Small molecule | Respiratory |Organon & Co.|Last Updated: May 10, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00127166Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)PHASE3 COMPLETED 154 — — Dec 1, 2005Nov 1, 2008May 10, 2024 - —
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Study Endpoints
Primary Endpoints
Maximum Post-exercise Percent (%) Fall in FEV1
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

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.

Secondary Endpoints
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Maximum FEV1 % Predicted Following First Beta-agonist Use
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Time to Recovery to Within 5% of Baseline FEV1
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Montelukast/SalmeterolEXPERIMENTALPeriod I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Salmeterol/MontelukastEXPERIMENTALPeriod I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
Interventions
NameTypeDescription
Montelukast sodiumDRUGMontelukast 5 mg chewable tablet once daily
Salmeterol xinafoateDRUGSalmeterol 50 mcg dry powder per actuation inhaled twice daily
Fluticasone propionateDRUGFluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Montelukast matching placeboDRUGMatching placebo to montelukast oral tablet administered once daily.
Salmeterol matching placeboDRUGMatching placebo to salmeterol dry powder for inhalation administered twice daily
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Eligibility Criteria
Age Range6 Years — 14 Years
SexALL
Healthy VolunteersNo

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

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