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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00597064
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: November 2007
  Purpose

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 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Quality of life, Sputum and nasal cytology, adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    Drug: prednisone
    oral prednisone 40 mg/day for 15 +/- 5 days
    Other Name: prednisone or placebo radom assigned
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?

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597064

Contacts
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

Locations
Brazil
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         
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Ana Luisa G Fernandes, MD, PhD Federal University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Ana Luisa Godoy Fernandes, Federal University of Sao Paulo- Respiratory Division
ClinicalTrials.gov Identifier: NCT00597064     History of Changes
Other Study ID Numbers: APITA, FAPESP PROTOCOL, 2005/04714-1
Study First Received: January 8, 2008
Last Updated: January 16, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
asthma
asthma control questionnaire
oral corticosteroid
air trapping
AQLQ
control
quality of life

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014