Last updated: 07/09/2020 20:10:09
Phenotypes of Severe Asthma among Adults in Brazil: a descriptive report of characteristics of subjects followed up in the ProAR Cohort
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Phenotypes of Severe Asthma among Adults in Brazil: a descriptive report of characteristics of subjects followed up in the ProAR Cohort
Trial description: The objective of study is to describe the proportion of severe asthma patients eligible for one or more currently available monoclonal antibody treatments (mepolizumab, omalizumab and reslizumab) and to characterize the frequency of parasitic disease among eosinophilic asthma patients. Also, this study will describe healthcare resource utilization, quality of life and asthma control in the severe asthma population.This will be an observational, bidirectional, longitudinal study of patients with severe asthma. In the retrospective phase, the data analysed will be those from the severe asthma patients that participated in a previously conducted case control study. For the prospective phase, a new study visit (V2), at least 1 year after the previous visit (Visit 1), will be scheduled to collect data on asthma control, quality of life, healthcare resource utilization, and work absenteeism using patient questionnaires.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Retrospective phase: Blood eosinophil levels in severe asthma patients
Timeframe: One time
Retrospective phase: Proportion of eosinophils based on different cut-off points in severe asthma patients
Timeframe: One time
Retrospective phase: Healthcare resource utilization for severe asthma patients
Timeframe: Last 12 months
Retrospective phase: asthma control in severe asthma patients
Timeframe: One time
Retrospective phase: Population of adults with severe asthma patients eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: One time
Prospective phase: Treatment patterns for severe asthma patients eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: Last 12 months and during visit 2 date
Secondary outcomes:
Retrospective phase: Baseline visit Spirometry
Timeframe: One time
Retrospective phase: Baseline visit Blood biomarkers
Timeframe: One time
Retrospective phase: Baseline visit atopy status
Timeframe: One time
Prospective phase: Healthcare resource utilization for subgroups eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: Last 12 months
Prospective phase: HR-Qol and asthma control for subgroups eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: One time
Prospective phase: Absenteeism for subgroups eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: One time
Prospective phase: Asthma symptoms for subgroups eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: One time
Prospective phase: Asthma control for subgroups eligible to receive mepolizumab, omalizumab and reslizumab
Timeframe: One time
Prospective phase: Clinical, demographic, and health characteristics for severe asthma patients subgroups
Timeframe: One time
Prospective phase: Healthcare resource utilization and asthma control (ACQ6) results for severe asthma patients subgroups
Timeframe: Last 12 months
Interventions:
Other: N/A
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
2017-19-10
Time perspective:
Other
Clinical publications:
Mello, LM; Viana, KP; dos Santos, FM; Saturnino, LTM; Kormann, M; Lazaridis E; Torreão CD; Soares CR; Abreu GA; Lima, VB; Pinheiro, GP; Lima-Matos, A; Ponte, E; Mohan, D; Riley J; Cruz, AA. Severe asthma and eligibility for biologics in a Brazilian Cohort. J Asthma. 2020
DOI: 10.1080/02770903.2020.1748049
Pub Med ID: 32270729
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
January 2017 to October 2017
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Not applicable
- Inclusion criteria
- Subject recorded as severe asthma patients on the database of the previously conducted case-control study “Risk factors, endophenotypes and biomarkers of severe asthma”
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria
- Subjects enrolled in the outpatient clinics of Program for Control of Asthma (ProAR,) which met the criteria of diagnosis of asthma. Patients classification included a chart audit by two experts in asthma to validate the diagnosis of asthma; Aged >= 18 years and =<40 years.
- Previous diagnosis of Chronic Obstructive Pulmonary Disease (COPD); Smokers with greater than or equal to 10 pack-year and Patients did not sign the Informed consent form (ICF) were excluded.
- Patients who agree to participate in the study by signing an ICF or Patients who meet at least one criteria for a special authorization from the ethics committees. Patients may consent to allow just the analysis of the case-control database and medical chart (retrospective part) and also may consent for both retrospective and prospective phase (visit 2). Exclusion Criteria
- Patients using omalizumab at least once before visit 1; Additionally, patients that participated in an interventional clinical trial in the last 12 months will be excluded from visit 2.
Subject recorded as severe asthma patients on the database of the previously conducted case-control study “Risk factors, endophenotypes and biomarkers of severe asthma”
Trial location(s)
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2017-19-10
Actual study completion date
2017-19-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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