Risk Factors Associated to Difficult-to-control Asthma

• Status: Completed
• Trial end date: 2009-05-13
• Target enrollment: 0
• Participant gender: All

Summary

Several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control.

The aim of this study is to measure asthma control, evaluate inflammatory and functional characteristics, describe comorbidities and aggravating factors and phenotypes derived from the characteristics of a severe asthmatic population followed at an outpatient university service in Sao Paolo, Brazil.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rafael Stelmach; University of Sao Paulo General Hospital
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

Criteria

Inclusion Criteria:

• Age between 18 and 65 years

• Diagnosis of moderate to severe asthma (GINA) for at least one year

• Presence of airway obstruction reversibility (documented within the last 5 years before the start-up of study)

• Smoking, non-smoking or ex-smoking patients of <30 pack-years.

• Need of inhaled corticosteroid (IC),> or equal 1000mcg of Beclomethasone Dipropionate (DPB) or similar in the last year plus beta 2 long duration agonist in the last year.

• At least one exacerbation with the need of oral corticosteroid in the last year.

Exclusion Criteria:

• Pregnant women;

• Co-morbidities that may interfere with the management of the study;

• Patients who cannot understand the procedures of the study or who are not able to provide their free and clarified consent;

• Patients with other pulmonary diseases which may interfere with the evaluation of the study.