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Clinical trial of dupilumab versus omalizumab in patients with severe chronic rhinosinusitis with nasal polyps and concomitant asthma.

THE SYMPTOMS OF CRS WITH NASAL POLYPS AND ASTHMA HAVE A GREAT EFFECT ON PATIENTS' QUALITY OF LIFE. SYMPTOMS SUCH AS NASAL CONGESTION, LOSS OF SENSE OF SMELL AND POOR LUNG FUNCTION NEGATIVELY AFFECT THE SMELL, BREATHING AND LIFE OF PEOPLE WITH THIS CONDITION. THEREFORE, ONE OF THE GOALS OF TREATMENT IS TO REDUCE THESE SYMPTOMS IN ORDER TO IMPROVE THE QUALITY OF LIFE OF PEOPLE WITH THIS CONDITION. THE PURPOSE OF THIS STUDY IS TO EVALUATE WHETHER DUPILUMAB WORKS BETTER THAN OMALIZUMAB; BOTH DRUGS ARE ALREADY APPROVED FOR CRS SYMPTOMS WITH NP AND ASTHMA. THIS STUDY WILL EVALUATE WHETHER IT REDUCES NASAL POLYPS AND IMPROVES THE SENSE OF SMELL, DECREASES NASAL CONGESTION, IMPROVES LUNG AND NASAL FUNCTION, AND IMPROVES PATIENTS' OVERALL QUALITY OF LIFE.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • A RANDOMIZED, DOUBLE-BLIND, HEAD-TO-HEAD COMPARISON STUDY OF DUPILUMAB VS. OMALIZUMAB IN PATIENTS WITH SEVERE CHRONIC RHINOSINUSITIS WITH NASAL POLYPS (CRS WITH NASAL POLYPS) AND CONCOMITANT ASTHMA.IMMUNOTHERAPY.
  • Code EudraCT: 2021-000829-27
  • Protocol number: LPS16747
  • Promoter: Sanofi-Aventis S.A.

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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