Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Federal University of São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo |
---|---|
Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00597064 |
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.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: prednisone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Inflammatory, Functional and Image Composite Measure to Define Asthma Control |
Estimated Enrollment: | 70 |
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?
Ages Eligible for Study: | 16 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contact: Ana Luisa G Fernandes, MD, PhD | 551150841268 | analgf@tewrra.com.br |
Contact: Maria Marta F Amorim, MSc | 55 11 50841268 | martafamorim@terra.com.br |
Brazil, Sao Paulo | |
Rua Botucatu 740 3 ° and - Pneumologia | Recruiting |
São Paulo, Sao Paulo, Brazil, 04023062 | |
Contact: Maria Marta F Amorim, MSc 55 11 50841268 martafamorim@terra.com.br | |
Contact: Patricia B Lima, Techinician 55 11 50841268 patricia@pneumo.epm.br | |
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 |
Responsible Party: | Federal University of Sao Paulo- Respiratory Division ( Ana Luisa Godoy Fernandes ) |
Study ID Numbers: | APITA, FAPESP PROTOCOL, 2005/04714-1 |
Study First Received: | January 8, 2008 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00597064 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
asthma asthma control questionnaire oral corticosteroid air trapping |
AQLQ control quality of life |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Asthma Quality of Life |
Glucocorticoids Hormones Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Bronchial Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Asthma Glucocorticoids |
Hormones Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |