AsthmaNCT07567690
Real-world Immunogenicity of Anti-IL5/5a Antibody
An observational study of Asthma and Immunogenicity, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Immunogenicity, Biologics
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Aug 2025to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with severe asthma
Who may be able to join
- Patients with severe asthma
Who cannot join
- History of hypersensitivity reactions to biologics (anti IL5 or IL5Ra)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study of Biologic Treatment and Outcomes in Patients With Severe Asthma (BREATH)
This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.
- Conditions
- Asthma, Immunogenicity, Biologics
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Patients with severe asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of clinically significant asthma exacerbations
Annualized rate of clinically significant asthma exacerbations
Measured: 12 month
Number of participants experiencing at least one asthma exacerbation
Number of participants experiencing at least one asthma exacerbation
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start19 Aug 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noeul KANG, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567690
- Sponsor's protocol ID
- 2025-05-028
- Other IDs
- SMO1250661
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Biologic Treatment and Outcomes in Patients With Severe Asthma (BREATH)
- ClinicalTrials.gov ID
- NCT07567690
- Acronym / sponsor ID
- 2025-05-028
- Conditions
- Asthma, Immunogenicity, Biologics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 May 2026 (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.
This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe asthma | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe asthma
Key inclusion criteria (1 listed)
- Patients with severe asthma
Key exclusion criteria (1 listed)
- History of hypersensitivity reactions to biologics (anti IL5 or IL5Ra)
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
Annualized rate of clinically significant asthma exacerbations
Time frame: 12 month
Annualized rate of clinically significant asthma exacerbations
Number of participants experiencing at least one asthma exacerbation
Time frame: 12 month
Number of participants experiencing at least one asthma exacerbation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Immunogenicity, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Annualized rate of clinically significant asthma exacerbations (time frame: 12 month). 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?
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 5 May 2026.