A Phase 2, Randomized, Double-Blind, 4-week Crossover Trial to Investigate the Effect of a Once-Daily Combination of 500 µg Roflumilast Plus 10 mg Montelukast vs 10 mg Montelukast Alone on Pulmonary Function, Asthma Symptoms, and Inflammatory Markers in Subjects With Severe Asthma Not Adequately Controlled With a Combination of at Least Medium Dose Inhaled Corticosteroids and Long-Acting Beta Agonists Maintenance Therapy

Trial Profile

A Phase 2, Randomized, Double-Blind, 4-week Crossover Trial to Investigate the Effect of a Once-Daily Combination of 500 µg Roflumilast Plus 10 mg Montelukast vs 10 mg Montelukast Alone on Pulmonary Function, Asthma Symptoms, and Inflammatory Markers in Subjects With Severe Asthma Not Adequately Controlled With a Combination of at Least Medium Dose Inhaled Corticosteroids and Long-Acting Beta Agonists Maintenance Therapy

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Feb 2017

At a glance

  • Drugs Roflumilast (Primary) ; Montelukast
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 23 Feb 2016 Primary endpoint of change from baseline in pre-dose (trough) pre-bronchodilator forced expiratory volume in 1 second (FEV1) has not been met, according to results published in the Journal of Allergy and Clinical Immunology.
    • 23 Feb 2016 Results published in the Journal of Allergy and Clinical Immunology
    • 05 Feb 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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