Inflammatory, Functional and Image Composite Measure to Define Asthma Control (APITA)
Recruitment status was: Recruiting
|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
|Rua Botucatu 740 3 ° and - Pneumologia|
|São Paulo, Sao Paulo, Brazil, 04023062|
|Principal Investigator:||Ana Luisa G Fernandes, MD, PhD||Federal University of Sao Paulo|