Inflammatory, Functional and Image Composite Measure to Define Asthma Control
Status:
Unknown status
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
The goals of control status of asthma have been changed with the improvement of its
management as a chronic disease; many steps should be taken to achieve asthma control as
defined by the GINA/NIH guidelines. There are good results with single variables, but overall
asthma control should be addressed in different ways. Most traditional clinical studies
provide an incomplete assessment of disease control, despite good clinical practice. The
association of inhaled corticosteroid (IC) and long-action beta 2 agonist (LABA) has already
showed their efficacy to reduce asthma symptoms, exacerbations and cost for moderate and
severe asthma patients as well as the improvement in their quality of life. On the other
hand, even with the use of first line maintenance medication, as recommended by guidelines,
some asthmatic patients fail in obtaining a total control of the disease. This lack of
efficacy, led us to hypothesize, that these patients who fail in response, would present
chronic and fixed airway obstruction as a consequence of persistent inflammation and airway
remodeling. This study has the purpose of looking for an adequate composite measure to
provide an indicator of overall asthma status more accurately and meaningfully as reflect of
treatment effectiveness and disease control. For this, we will test by a randomized control
trial if an additional oral corticosteroid treatment could modify spirometric and
plethysmography values, nasal and low airway cytology and HRCT (to evaluate small airway) in
regularly treated stable asthma patients who have a positive bronchodilator response.
Phase:
Phase 4
Details
Lead Sponsor:
Federal University of São Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo