Clinical trial · Interventional
Risk Factors Associated to Difficult-to-control Asthma
Risk Factors Associated to Difficult-to-control Asthma: Characterization of Clinical, Structural and Inflammatory Factors Related to Treatment Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ASTHMA | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| inhaled corticosteroid plus LABA plus oral corticosteroid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stantardized treament
- description
- oral and inhaled corticosteroid plus LABA
- interventionNames
- Drug: inhaled corticosteroid plus LABA plus oral corticosteroid
Primary outcomes (1)
- measure
- Asthma control questionnaire (ACQ)
- timeFrame
- Baseline, after 2 weeks of oral corticosteroid trial and after 12 weeks of inhaled corticosteroid plus LABA
- description
- 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
Secondary outcomes (1)
- measure
- Inflammatory parameters
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDAthanazio 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
- DERIVEDde 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