Inflammatory, Functional and Image Composite Measure to Define Asthma Control (APITA)
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|ClinicalTrials.gov Identifier: NCT00597064|
Recruitment Status : Unknown
Verified November 2007 by Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: prednisone||Phase 4|
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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inflammatory, Functional and Image Composite Measure to Define Asthma Control|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||March 2008|
|Estimated Study Completion Date :||March 2008|
- Drug: prednisone
oral prednisone 40 mg/day for 15 +/- 5 daysOther Name: prednisone or placebo radom assigned
- 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 ]
- Quality of life, Sputum and nasal cytology, adverse events [ Time Frame: 30 days ]
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): 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|