Inflammatory, Functional and Image Composite Measure to Define Asthma Control

NCT00597064 | Unknown Phase 4 DMC

• 3 other identifiers: APITAFAPESP PROTOCOL2005/04714-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; asthma control questionnaire; oral corticosteroid; air trapping; AQLQ; control; quality of life

Outcome Measures

Primary Outcomes (1)

• Asthma control status characterized by nocturnal and diurnal symptom score FEV1,total lung capacity in plethysmography and reducing the air-tapping in HRCT.

  30 days

Secondary Outcomes (1)

• Quality of life, Sputum and nasal cytology, adverse events

  30 days

Interventions

prednisone DRUG

oral prednisone 40 mg/day for 15 +/- 5 days

Also known as: prednisone or placebo radom assigned

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Rua Botucatu 740 3 ° and - Pneumologia

São Paulo, São Paulo, 04023062, Brazil

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ana Luisa G Fernandes, MD, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Luisa G Fernandes, MD, PhD

CONTACT

551150841268; analgf@tewrra.com.br

Maria Marta F Amorim, MSc

CONTACT

55 11 50841268; martafamorim@terra.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: July 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 17, 2008

Record last verified: 2007-11

Locations

BR (1)