Efficacy and Safety of Two Dry Power Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma
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|ClinicalTrials.gov Identifier: NCT00975741|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : September 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: OXIMAX Device: ASMANEX TWISTHALER||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Comparative, Randomized, Parallel, Multicenter Study to Determine the Efficacy and Safety of Two Dry Powder Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||August 2003|
Experimental: Monodose device
Mometasone furoate 400 µg DPI capsules administered through a monodose device.
Active Comparator: Multidose device
Mometasone furoate 400 µg DPI capsules administered through a multidose device
Device: ASMANEX TWISTHALER
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975741
|Hospital Universitário da Universidade Federal de Juíz de Fora|
|Juíz de Fora, Minas Gerais, Brazil|
|Rio de Janeiro, Brazil|
|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, Brazil|
|Hospital do Servidor Público Estadual|
|São Paulo, Brazil|
|São Paulo, Brazil|
|Principal Investigator:||Carlos Alberto C Pereira, MD, PhD||Hospital do Servidor Público Estadual, São Paulo|