Risk Factors Associated to Difficult-to-control Asthma

NCT01089322 | Completed Phase 4

• 1 other identifier: OBSTRUÇÃOHC-02
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ASTHMA

Keywords

SEVERE ASTHMA; RISK FACTORS; CHARACTERIZATION; CLINICAL CONTROL; INFLAMMATORY MARKERS; SEVERE; CONTROL

Outcome Measures

Primary Outcomes (1)

• Asthma control questionnaire (ACQ)

  Compare ACQ score in baseline and after 2 weeks of oral plus inhaled corticosteroid plus LABA and after 12 weeks of inhaled corticosteroid plus LABA

  Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA

Secondary Outcomes (1)

• Inflammatory parameters

  Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA

Study Arms (1)

Stantardized treament

EXPERIMENTAL

oral and inhaled corticosteroid plus LABA

Drug: inhaled corticosteroid plus LABA plus oral corticosteroid

Interventions

inhaled corticosteroid plus LABA plus oral corticosteroid DRUG

formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg

Also known as: inhaled corticosteroid, LABA, oral corticosteroid

Stantardized treament

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rafael Stelmach: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo - Heart Institute and Hospital das Clínicas

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

• Athanazio R, Carvalho-Pinto R, Fernandes FL, Rached S, Rabe K, Cukier A, Stelmach R. Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic. BMC Pulm Med. 2016 Nov 16;16(1):153. doi: 10.1186/s12890-016-0314-1.

  PMID: 27852260 DERIVED

• de Carvalho-Pinto RM, Cukier A, Angelini L, Antonangelo L, Mauad T, Dolhnikoff M, Rabe KF, Stelmach R. Clinical characteristics and possible phenotypes of an adult severe asthma population. Respir Med. 2012 Jan;106(1):47-56. doi: 10.1016/j.rmed.2011.08.013. Epub 2011 Sep 3.

  PMID: 21890336 DERIVED

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Regina M. Carvalho Pinto, MD

  Heart Institute, University of São Paulo

  PRINCIPAL INVESTIGATOR

• Rafael Stelmach, PhD

  Heart Institute, University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study. All subjects received the same treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD-PHD

Model Details: Retrospective analysis after treatment outcome (controlled vs. non controlled) based on the primary outcome; and post hoc analysis after oral steroid treatment based on pulmonary function reversibility

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: March 18, 2010
• Study Start: December 9, 2005
• Primary Completion: April 3, 2009
• Study Completion: May 13, 2009
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

BR (1)