The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.
The primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms. Primary endpoint: Forced expiratory volume in 1 second (FEV1) at the final visit. Secondary endpoints: Expiratory Flow Peak (EFP), symptoms score, FEV1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Hospital de Clinicas UFPR
Curitiba, PR, Brazil
Centro de Referencia em Enfermidades Respiratoria e Alergica
Salvador, BA, Brazil
Centro de Estudos de Pneumologia FMABC
São Paulo, Brazil
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil
Forced expiratory volume in 1 second (FEV1) at the final visit.
Expiratory Flow Peak (EFP)
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Stelmach Pesquisa Clinica
São Paulo, Brazil
Clinica de Alergia Martti Antila
Sorocaba, SP, Brazil