Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.
Background: Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. Results of laboratory analysis for respirable fraction, content uniformity of emitted dose and of the bulk powder and for percentage of particles \< 1 micra of both MF 200 µg and MF 400 µg capsules have indicated their equivalent performance in comparison to MF DPI multidose. Aim: The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety. Methods: Ninety-seven adult patients with moderate persistent asthma were randomized in two groups to receive for 60 days a dose of 400 µg of DPI MF once daily (at evening) using multidose or monodose device. Follow-up visits were scheduled at Days 7, 14, 28, 42 and 56. Efficacy was assessed by means of pulmonary function tests (spirometry - FEV1 and PEFR) at each visit. In addition, subjects have recorded twice daily PEFR, symptom scores and use of rescue medication throughout the study. Response to therapy was also assessed. Safety evaluations included monitoring of adverse events, vital signs, clinical laboratory tests (plasma cortisol concentrations were assessed at enrollment and repeated after 60 days of MF treatment; cortrosyn test was performed at the enrollment and after 60 days of MF treatment), and physical examination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Hospital Universitário da Universidade Federal de Juíz de Fora
Juíz de Fora, Minas Gerais, Brazil
UNIRIO
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Hospital do Servidor Público Estadual
São Paulo, São Paulo, Brazil
Difference in Forced Expired Volume in one second (FEV1) and Peak Expiratory Flow Rate (PEFR) measured by spirometry; number of puffs/day of rescue medication (Salbutamol) used by the subjects.
Time frame: 56 days after initiation of therapy
PEFR daily measurements, daily scores for asthma symptoms, response to therapy made by the Investigator, safety (hypothalamic-pituitary-adrenal axis evaluation and clinical laboratory measurements) and tolerability (adverse events).
Time frame: 56 days after initiation of therapy
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Enrollment
97
Hospital Heliópolis
São Paulo, São Paulo, Brazil