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Salmeterol xinafoate · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Montelukast/Salmeterol | EXPERIMENTAL | Period 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/Montelukast | EXPERIMENTAL | Period 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. |
| Name | Type | Description |
|---|---|---|
| Montelukast sodium | DRUG | Montelukast 5 mg chewable tablet once daily |
| Salmeterol xinafoate | DRUG | Salmeterol 50 mcg dry powder per actuation inhaled twice daily |
| Fluticasone propionate | DRUG | Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily |
| Montelukast matching placebo | DRUG | Matching placebo to montelukast oral tablet administered once daily. |
| Salmeterol matching placebo | DRUG | Matching placebo to salmeterol dry powder for inhalation administered twice daily |
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
Salmeterol xinafoate is used for the prevention of airway constriction brought on by exercise in participants with exercise-induced asthma. It is a small molecule being developed by Organon & Co. for the respiratory therapeutic area.
Salmeterol xinafoate is being developed by Organon & Co., which trades under the ticker OGN. The company is conducting clinical research on this small molecule for the treatment of exercise-induced asthma.
Salmeterol xinafoate is in Phase 3 clinical development. It is an investigational drug for exercise-induced asthma and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Salmeterol xinafoate has one completed Phase 3 trial, NCT00127166, titled "Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)." The trial enrolled 154 participants with exercise-induced asthma.
Salmeterol xinafoate is a salt form of salmeterol, a long-acting beta agonist. The xinafoate salt is used in the pharmaceutical formulation. In clinical trials, it is studied for its ability to prevent exercise-induced bronchoconstriction in asthma patients.