Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Asthma, Allergic
  • Rhinitis Allergic
  • Rhinoconjunctivitis
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group studyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed. So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.Primary Purpose: Treatment

Participation Requirements

Age
Between 14 years and 65 years
Gender
Both males and females

Description

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 14 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 14 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Tracking Information

NCT #
NCT04435990
Collaborators
Not Provided
Investigators
Principal Investigator: Daniel Pujadas, MD Quirón Palma de Mallorca Principal Investigator: Mario Tubella, MD Cenvi Medic, Barcelona Principal Investigator: Alfonso Malet, MD Allergocentre, Barcelona Principal Investigator: Miguel Ángel Añó, MD Alergocantabria, Santander Principal Investigator: Miguel Herrías, MD Clinica Privada Bilbao Principal Investigator: Antonio Letrán, MD Hospital HLA Jeréz Puerta del Sur Principal Investigator: Diego Gutiérrez, MD Clínica Virgen del Rosario, Algeciras Principal Investigator: Ignacio Garcia, MD Clinica Quirón Salud, Córdoba Principal Investigator: Manuel Barceló, MD Clinica Privada, Málaga. Principal Investigator: Mº José Pereira, MD Centro Médico Puerto, Jerez Principal Investigator: Isabella Raducán, MD Clínica TECMA, Alzira Principal Investigator: Noelia Colomer, MD Clínica IMED, Valencia Principal Investigator: Eugenia Margarita Campos, MD Clínica IMED, Elche Principal Investigator: César Alías, MD Clínica Corachan, Barcelona Principal Investigator: Joaquín Martín, MD Hospital POLUSA, Lugo