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Severe AsthmaBRAEOSNCT03925415

BRazilian Asthmatics Patients EOSinophilic Profile (BRAEOS)

An observational study of Severe Asthma, run by AstraZeneca at 6 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Asthma is a complex and heterogeneous disease. Severe asthma is recognised as a major unmet need that poses a great burden on the healthcare system. While accounting for only a small proportion of the total asthmatic population, asthma-related costs are 1.7 to 4-fold higher than those observed in the mild-persistent… Read more about this study

Who is it for?
Any age
Conditions the study is for
Severe Asthma
How many people
414 participants
Where
6 sitesBrazil
Study dates
24 Jan 2019to 15 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population will include adult patients with severe asthma, as per the definition of the International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma, and who attend their routine clinical appointment at Brazilian centres specialized in the management of severe asthma.

Who may be able to join

  • Male or female subject, aged 18 years or older at the time of study entry.
  • Subject followed at a participating centre and attending a routine clinical appointment.
  • Subjects with evidence of asthma of either:
  • Documented airway reversibility (forced expiratory volume in one second (FEV1) ≥12% and 200 mL) using the maximum post-bronchodilator procedure OR
  • Documented airway hyperresponsiveness (provocative concentration of methacholine causing a ≥20% fall in FEV1) OR
  • Documented airflow variability in FEV1 ≥20% between two consecutive lung function assessments prior to study entry (FEV1 values recorded during exacerbations should not be considered for this criterion)
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  • Subjects with a diagnosis of severe asthma for at least one year, according to the criteria of the International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma (6), i.e.:
  • Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma (high dose ICS (Appendix A) and LABA or leukotriene modifier/theophylline) for the previous year; or
  • Systemic CS for ≥50% of the previous year to prevent it from becoming "uncontrolled" or which remains "uncontrolled" despite this therapy.
  • Subject with accurate and complete medical records at the centre.
  • Subject that voluntarily signed and dated the informed consent form prior to study entry.

Who cannot join

  • Subjects experiencing a moderate or severe asthma exacerbation as per the Official ATS/ERS Statement on Asthma Control (22) at the time of the study entry, or who had a moderate or severe asthma exacerbation less than 4 weeks prior to study entry.
  • Subjects whose pharmacological therapy for asthma was modified in the 3 months prior to study entry.
  • Subjects diagnosed with at least one of the following:
  • Lung cancer
  • Pulmonary fibrosis
  • Allergic bronchopulmonary aspergillosis
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  • Eosinophilic granulomatosis with polyangiitis
  • Clinically relevant bronchiectasis or bronchiectasis associated with cystic fibrosis and/or allergic bronchopulmonary aspergillosis.
  • Chronic obstructive pulmonary disease associated with a smoking history ≥10 pack-years and/or history of exposure to biomass fuel combustion
  • Subjects who are currently smokers or who have a history of smoking ≥ 10 pack-years.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Brazil6 sites
  • Research Site

    Blumenau, 89030-101

  • Research Site

    Goiânia, 74110 030

  • Research Site

    Londrina, 86057-970

  • Research Site

    Porto Alegre, 90610-000

  • Research Site

    São Paulo, 05403-000

  • Research Site

    Sorocaba, 18040-425

Other trials in Brazil

About this study

Official title: A National, Observational, Cross-Sectional, Multicenter Study to Estimate the Prevalence of an Eosinophilic Phenotype Among Severe Asthma Patients in Brazil

Asthma is a complex and heterogeneous disease. Severe asthma is recognised as a major unmet need that poses a great burden on the healthcare system. While accounting for only a small proportion of the total asthmatic population, asthma-related costs are 1.7 to 4-fold higher than those observed in the mild-persistent asthma population and the associated personal and societal impact is significant.

Severe asthma is not considered to be a single disease, but can be divided into several phenotypes, owing to the variety of inflammatory, clinical and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied with a high concentration of eosinophils require greater healthcare resource use, overall greater disease management costs and have a much more impaired QoL than those who do not present with raised eosinophilia.

Read more

While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses and inflammatory processes involved represents an added challenge for health care professionals. Thus, severe asthma management is a complex endeavour and a thorough and up to date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making.

The purpose of this observational, cross-sectional, multicentre study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count > 300 cells/mm3 among severe asthma patients followed at Brazilian sites specialized in the management of severe asthma. The prevalence of an atopic phenotype, asthma control, QoL and burden of disease will also be studied.

Read the detailed description

Knowledge of the prevalence of eosinophilia among adult, severe asthma patients in Brazil is limited. Moreover, data on the prevalence of an atopic phenotype within the adult, severe asthma population is scarce. Severe asthma management is a complex endeavour and a thorough and up to date understanding of the pathophysiologic characteristics of the patient population facilitates therapeutic decisions that effectively lead to disease control.

The purpose of this observational, cross-sectional, multicentre study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count > 300 cells/mm3 among severe asthma patients followed at Brazilian sites specialized in the management of severe asthma. The prevalence of an atopic phenotype, asthma control, QoL and burden of disease will also be studied. It is expected that this study will contribute to the understanding of severe asthma in Brazil, ultimately helping to inform therapeutic decisions and addressing patients' needs.

Conditions
Severe Asthma
Keywords
Severe Asthma, Eosinophilic Asthma, Eosinophilic Phenotype
Medical subject headings
Asthma, Pulmonary Eosinophilia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of an eosinophilic phenotype of blood eosinophil count > 300 cells/mm3 among severe asthma patients in Brazil.

    Measured: 8-month

Secondary outcomes (10)
  1. Prevalence of an eosinophilic phenotype of blood eosinophil count > 150 cells/mm3.

    Measured: 8-month

  2. Prevalence of an atopic phenotype, defined by a pre-existing history of atopy and total serum IgE > 100 UI/mL.

    Measured: 8-month

  3. Prevalence of atopy, as defined by a pre-existing history of atopy and total serum IgE > 100 UI/mL, among patients that present an eosinophilic phenotype of blood eosinophil count > 300 cells/mm3.

    Measured: 8-month

  4. Annual exacerbation rate.

    Measured: 12-month

  5. Patient-reported QoL using the St. George's Respiratory Questionnaire (SGRQ) results.

    The SGRQ allows for the assessment of QoL of asthma patients. The questionnaire evaluates three domains: patient's perception of their recent respiratory problems (Symptoms score), disturbances to daily physical activity (Activity score) and disturbances of psycho-social function (Impact score). The score of each component and a total score can be computed. Scores are expressed as a percentage of overall impairment, where 100 represent the worst health status and 0 indicates the best status. Variables to collect: Symptoms score, Activity score, Impact score and Total score.

    Measured: 8-month

  6. Asthma control using the Asthma Control Questionnaire 7 (ACQ 7) results.

    The ACQ 7 allows for the evaluation of asthma control. Subjects will be asked to respond to six questions pertaining to asthma-related symptoms and bronchodilator use on a 7-point scale (where 0=no impairment and 6=maximum impairment). The seventh question will be answered by the study's team at the research center and involves scoring the FEV1% predicted on a 7-point scale. The total ACQ 7 score is computed through the mean of the 7 questions and, as such, varies between 0 (totally controlled asthma) and 6 (severely uncontrolled asthma). Variables to collect include the responses to each of the questionnaire's individual items.

    Measured: 8-month

  7. Burden of disease using the GAD 7 scale.

    The Generalized Anxiety Disorder (GAD -7) is a self-administered patient questionnaire used as a screening tool and as a severity measure for patients with generalized anxiety disorder. It is composed by 7 items: (1) feeling nervous, (2) not being able to stop or control worrying, (3) worrying too much about different things, (4) trouble relaxing, (5) being so restless that it is hard to sit still, (6) becoming easily annoyed or irritable, and (7) feeling afraid as if something awful might happen. Through a 4-point Likert scale from 'not at all' to 'nearly every day', it is asked how often the patient has been bothered by any of the presented problems. The GAD-7 index is obtained by adding the scores from the questionnaire, after having assigned 0 to the least severe situation, 3 to the most severe one, and 1 and 2 to the intermediate ones. The cut off points 5, 10 and 15 allow to classify the anxiety as none/normal (0-4), mild (5-9), moderate (10-14), and severe (15-21).

    Measured: 8-month

  8. Burden of disease using the PHQ-9.

    The Patient Health Questionnaire (PHQ) is a self-administered instrument for common mental disorders. The PHQ-9 is the depression module from the full PHQ and consists of 9 questions that assess the presence of each of the symptoms for the episode of major depression. The PHQ-9 score can range from 0-27, since each of the 9 items can be scored from 0-3 corresponding to "no at all", "several days", "more than half the days" and "nearly every day" responses, respectively. Major depression is diagnosed if 5 or more symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. Other depression is diagnosed if 2, 3, or 4 symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. One of the 9 symptom ("thoughts that you would be better off dead or of hurting yourself in some way") counts if present at all, regardless of duration.

    Measured: 8-month

  9. Burden of disease using the WPAI: Asthma questionnaire results.

    The WPAI assess the subject's ability to work and perform regular activities. The questionnaire inquiries about the number of days and hours missed from work or general activities. It also asks patients to rate, on a scale from 0 to 10, the degree to which asthma impairs productivity at work and their ability to perform normal daily activities. Higher values represent a more-severe impact. Variables to collect include the responses to each of the questionnaire's individual items.

    Measured: 8-month

  10. Chronic oral corticosteroid (OCS) rate.

    Measured: 8-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start24 Jan 2019
  3. Primary completion15 Oct 2019
  4. Study completion15 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03925415
Sponsor's protocol ID
D3250R00045
Acronym
BRAEOS
Status last verified
Aug 2020
First submitted
19 Feb 2019
Last updated
14 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Asthma, run by AstraZeneca at 6 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of an eosinophilic phenotype of blood eosinophil count > 300 cells/mm3 among severe asthma patients in Brazil. (time frame: 8-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.

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