Inflammatory, Functional and Image Composite Measure to Define Asthma Control (APITA)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Inflammatory, Functional and Image Composite Measure to Define Asthma Control|
- Asthma control status characterized by nocturnal and diurnal symptom score FEV1,total lung capacity in plethysmography and reducing the air-tapping in HRCT. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Quality of life, Sputum and nasal cytology, adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||March 2008|
|Estimated Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
To evaluate the achievement of asthma control status in asthmatic patients, regularly treated with IC + LABA to answer the following questions:
i. Is it possible to improve the pulmonary function (spirometry and plethysmography) of stable asthma patients, regularly treated with IC + LABA, who have a positive bronchodilator response, with the introduction of oral steroid?
ii. What is the relationship among nasal, induced sputum and blood cytology, as a tool to observe inflammatory airway expression, in controlled and total controlled asthma patients? What will be these values response if oral steroids have been introduced?
iii. What is the correlation between pulmonary volumes and airways inflammation to evaluate severity and control status in asthmatic patients, using plethysmography and HRCT? What will be these values response if oral steroids have been introduced?
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597064
|Contact: Ana Luisa G Fernandes, MD, PhDfirstname.lastname@example.org|
|Contact: Maria Marta F Amorim, MSc||55 11 email@example.com|
|Rua Botucatu 740 3 ° and - Pneumologia||Recruiting|
|São Paulo, Sao Paulo, Brazil, 04023062|
|Contact: Maria Marta F Amorim, MSc 55 11 50841268 firstname.lastname@example.org|
|Contact: Patricia B Lima, Techinician 55 11 50841268 email@example.com|
|Principal Investigator: Ana Luisa G Fernandes, MD, PhD|
|Sub-Investigator: Alexander Araruna, MD|
|Sub-Investigator: Maria Marta F Amorim, MSc|
|Principal Investigator:||Ana Luisa G Fernandes, MD, PhD||Federal University of Sao Paulo|