- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00597064
Inflammatory, Functional and Image Composite Measure to Define Asthma Control (APITA)
Study Overview
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Sao Paulo
-
São Paulo, Sao Paulo, Brazil, 04023062
- Recruiting
- Rua Botucatu 740 3 ° and - Pneumologia
-
Contact:
- Maria Marta F Amorim, MSc
- Phone Number: 55 11 50841268
- Email: martafamorim@terra.com.br
-
Contact:
- Patricia B Lima, Techinician
- Phone Number: 55 11 50841268
- Email: patricia@pneumo.epm.br
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Principal Investigator:
- Ana Luisa G Fernandes, MD, PhD
-
Sub-Investigator:
- Alexander Araruna, MD
-
Sub-Investigator:
- Maria Marta F Amorim, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- A documented clinical asthma history at least for a period of six months
- Regular treatment (IC + LABA) at least for a period of three months
- Controlled symptoms score defined by GINA 2002 criteria (daytime symptoms < 2 days a week and no night time symptoms in the last 15 days) or complete absence of chronic symptoms
- None or minimal exacerbations without emergency visits
- Absent or a minimal usage bronchodilator rescue, side effects of medication and limitation to exercises
- Documented airway reversibility of 200 ml and 7% based on predicted values of VEF1
Exclusion Criteria:
- Having a smoking history of 5 pack/years or more; having other known chronic pulmonary diseases; having side effect to oral corticosteroid
- Having an upper or lower respiratory tract infection within 4 weeks of visit 0
- Unable to do the tests involved in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life, Sputum and nasal cytology, adverse events
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Luisa G Fernandes, MD, PhD, Federal University of São Paulo
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- APITA
- FAPESP PROTOCOL
- 2005/04714-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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