Inflammatory, Functional and Image Composite Measure to Define Asthma Control (APITA)

January 16, 2008 updated by: Federal University of São Paulo

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 Overview

Status

Unknown

Conditions

Asthma

Intervention / Treatment

Drug: prednisone

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

Interventional

Enrollment (Anticipated)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- 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
    - Principal Investigator:
      
      Ana Luisa G Fernandes, MD, PhD
    - Sub-Investigator:
      
      Alexander Araruna, MD
    - Sub-Investigator:
      
      Maria Marta F Amorim, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Principal Investigator: Ana Luisa G Fernandes, MD, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

University home page

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Anticipated)

March 1, 2008

Study Completion (Anticipated)