Severe AsthmaPREPARENCT03931954
Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients
An observational study of Severe Asthma, run by AstraZeneca at 18 sites in 6 countries.
Trial summary
The purpose of this cross-sectional, multicenter study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients who attend to sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Asthma
- How many people
- 794 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 15 May 2019to 26 Nov 2020
- 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 patients from 12 years and older with severe asthma, as per the definition of the GINA 2018 Guidelines (GINA, 2018). Patients will be identified and invited to participate in the study consecutively, as they attend their routine clinical visit at the research centers. To be included in the study, each patient should meet all the inclusion criteria and none of the exclusion criteria described in the sections below. Patients should provide written, informed consent prior to any study-specific procedures. The enrolment period will be approximately 8 months or until the required number of patients has been included, whichever occurs first
Who may be able to join
- Patients must fulfil all of the following inclusion criteria to be included in the study:
- Male or female patient, aged 12 years or older by the time of study entry
- Patient visiting a participating center for a routine clinical appointment
- Patient is willing and able to provide a blood sample for IgE and eosinophil levels determination as part of their routine clinical visit
- Diagnosis of severe asthma for at least one year as defined by:
- Treatment with guidelines-suggested medications for Global Initiative for Asthma (3) steps 4-5 asthma
- Patients or their legal guardian, who voluntarily sign and date the informed consent form prior to study entry.
Who cannot join
- Patients with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory condition beyond severe asthma
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study Patients who are currently under a biologic therapy to treat their severe asthma
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Mexico5 sites
Research Site
Guadalajara
Research Site
Mérida
Research Site
Puebla City
Research Site
San Juan del Río
Research Site
Villahermosa
Colombia4 sites
Research Site
Barranquilla
Research Site
Bogotá
Research Site
Bucaramanga
Research Site
Pereira
Saudi Arabia4 sites
Research Site
Dammam
Research Site
Jeddah
Research Site
Riyadh, 111511
Research Site
Riyadh
About this study
Official title: PREPARE STUDY: PRevalence of the Eosinophilic Phenotype Among SeveRE Asthma Patients in AstraZeneca International Region. A Multinational, Cross-Sectional, Multicenter Study
The purpose of this cross-sectional, multicenter study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients who attend to sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and asthma control, will also be studied.
Read the detailed description
To determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients attending their routine clinical visit at sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and the status of asthma control, will also be studied. It is expected that this study will contribute to the understanding of severe asthma, ultimately helping to inform therapeutic decisions and addressing patients' needs.
- Conditions
- Severe Asthma
- Keywords
- eosinophilic asthma, severe asthma, prevalence, phenotype, atopic phenotype, eosinophilic phenotype
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients completing the inclusión criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Eosinophil count
The level of eosinophils in the blood will be assessed from this blood sample and reported
Measured: There is only one study visit. During that study visit the sample will be collected
Total serum IgE
Total serum IgE will be assessed from this blood sample and reported
Measured: There is only one study visit. during that visit the sample will be collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start15 May 2019
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 794 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maarten beekman, MD, Study chair, medical lead respiratory InternationalMonica Olmos, MD, Study chair, Study delivery lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931954
- Sponsor's protocol ID
- D2287R00140
- Acronym
- PREPARE
- Status last verified
- Jan 2021
- First submitted
- 10 Apr 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Jahdali H, Wali S, Albanna AS, Allehebi R, Al-Matar H, Fattouh M, Beekman M. Prevalence of eosinophilic, atopic, and overlap phenotypes among patients with severe asthma in Saudi Arabia: a cross-sectional study. BMC Pulm Med. 2022 Feb 17;22(1):67. doi: 10.1186/s12890-022-01856-9.
PubMed 35177038
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE STUDY: PRevalence of the Eosinophilic Phenotype Among SeveRE Asthma Patients in AstraZeneca International Region. A Multinational, Cross-Sectional, Multicenter Study
- ClinicalTrials.gov ID
- NCT03931954
- Acronym / sponsor ID
- PREPARE / D2287R00140
- Conditions
- Severe Asthma
- Keywords
- eosinophilic asthma, severe asthma, prevalence, phenotype, atopic phenotype, eosinophilic phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this cross-sectional, multicenter study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients who attend to sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and asthma control, will also be studied.
Detailed description
To determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients attending their routine clinical visit at sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and the status of asthma control, will also be studied. It is expected that this study will contribute to the understanding of severe asthma, ultimately helping to inform therapeutic decisions and addressing patients' needs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –Patients completing the inclusión criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients from 12 years and older with severe asthma, as per the definition of the GINA 2018 Guidelines (GINA, 2018). Patients will be identified and invited to participate in the study consecutively, as they attend their routine clinical visit at the research centers. To be included in the study, each patient should meet all the inclusion criteria and none of the exclusion criteria described in the sections below. Patients should provide written, informed consent prior to any study-specific procedures. The enrolment period will be approximately 8 months or until the required number of patients has been included, whichever occurs first
Key inclusion criteria (7 listed)
- Male or female patient, aged 12 years or older by the time of study entry
- Patient visiting a participating center for a routine clinical appointment
- Patient is willing and able to provide a blood sample for IgE and eosinophil levels determination as part of their routine clinical visit
- Diagnosis of severe asthma for at least one year as defined by:
- Treatment with guidelines-suggested medications for Global Initiative for Asthma (3) steps 4-5 asthma
Key exclusion criteria (2 listed)
- Patients with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory condition beyond severe asthma
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study Patients who are currently under a biologic therapy to treat their severe asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Eosinophil count
Time frame: There is only one study visit. During that study visit the sample will be collected
The level of eosinophils in the blood will be assessed from this blood sample and reported
Total serum IgE
Time frame: There is only one study visit. during that visit the sample will be collected
Total serum IgE will be assessed from this blood sample and reported
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 35177038Al-Jahdali H, Wali S, Albanna AS, Allehebi R, Al-Matar H, Fattouh M, Beekman M. Prevalence of eosinophilic, atopic, and overlap phenotypes among patients with severe asthma in Saudi Arabia: a cross-sectional study. BMC Pulm Med. 2022 Feb 17;22(1):67. doi: 10.1186/s12890-022-01856-9.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten beekman, MD study chair
medical lead respiratory International
Monica Olmos, MD study chair
Study delivery lead
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 18 sites in 6 countries.
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 7 inclusion and 2 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Mexico, Colombia, Saudi Arabia, Argentina, Chile and 1 more country. 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?
Blood Eosinophil count (time frame: There is only one study visit. During that study visit the sample will be collected). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931954, which also lists 1 linked publication.
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 29 Jan 2021.