An interventional study of Comprehensive Biomarker-Guided Management Strategy and Standard of Care in Asthma (Diagnosis), sponsored by Hana Serajeddini. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Hana Serajeddini · Not applicable, Interventional, and Treatment
The goal of this pilot clinical trial is to learn whether it is feasible to conduct a future larger trial of a comprehensive management strategy for adults with severe asthma who are starting biologic therapy.
The main questions this pilot study aims to answer are:
Can eligible participants be recruited and retained in the study? Can the study visits, tests, and other study procedures be successfully completed? Is the comprehensive management strategy acceptable to participants and clinicians? What proportion of participants receiving usual asthma care achieve asthma remission at 12 months?
Researchers will compare usual severe asthma care with a comprehensive management approach that uses specialized tests of airway inflammation and lung abnormalities to help doctors make treatment decisions.
Participants will be followed for 12 months. They will complete questionnaires, lung function tests, blood tests, and sputum testing. Clinically available CT scans obtained as part of usual care may also be used for study assessments. Participants may also choose to undergo optional research MRI scans.
Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.
This pilot randomized controlled trial will assess the feasibility of conducting a future full-scale randomized controlled trial evaluating whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The future full-scale trial will also evaluate whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care.
Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to specialized research biomarker results.
Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, and sputum cell analysis. Clinically available computed tomography (CT) imaging obtained as part of usual care may also be used for study assessments. Participants who consent to the optional magnetic resonance imaging (MRI) component may undergo research MRI assessments.
The findings from this pilot study will provide feasibility data and preliminary information regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and will inform the design of the future full-scale randomized controlled trial.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 50 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with Hana Serajeddini as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the comprehensive management arm will receive asthma management according to routine clinical practice in addition to a comprehensive management strategy. Specialized biomarker results from these specialized assessments will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management.
Other: Comprehensive Biomarker-Guided Management Strategy
Participants randomized to the standard of care arm will receive severe asthma management according to routine clinical practice. Specialized research biomarker assessments will be performed; however, these results will not be disclosed to the treating clinician and will not be used to guide clinical management. Treatment decisions will be based on routinely available clinical information and standard clinical practice.
Other: Standard of Care
Participants will receive asthma management according to routine clinical practice in addition to a comprehensive biomarker-guided management strategy. Specialized biomarker assessments, including sputum cell analysis and imaging biomarkers, will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management. Treatment decisions may be informed by these specialized biomarker results throughout the 12-month study period.
Participants will receive asthma management according to routine clinical practice. Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions. Treatment decisions will be based on routinely available clinical information and standard clinical practice.
Eligibility Rate
Percentage of individuals screened for the study who meet the study eligibility criteria. The eligibility rate will be calculated as the number of screened individuals who meet the eligibility criteria divided by the total number of individuals screened, multiplied by 100
Time frame: During the study recruitment period
Recruitment Rate
The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.
Time frame: During the study recruitment period
Enrolment Rate
The enrolment rate will be calculated as the number of eligible individuals enrolled divided by the total number of eligible individuals approached for participation, multiplied by 100.
Time frame: During the study recruitment period
Retention Rate
The retention rate will be calculated as the number of participants who complete the Month 12 follow-up divided by the total number of randomized participants, multiplied by 100.
Time frame: Baseline(randomization) through Month 12
Four-Domain Asthma Remission Rate in the Standard-of-Care Group
Percentage of participants randomized to the standard-of-care (control) group who meet the protocol-defined criteria for 4-domain asthma remission at Month 12. The remission rate will be a corresponding confidence interval and will be used to inform sample size calculations for a future full-scale randomized controlled trial.
Time frame: Baseline(randomization) through Month 12
Study Assessment Completion Rate
Percentage of scheduled study assessments completed by participants. The assessment completion rate will be calculated as the number of completed required study assessments divided by the total number of scheduled required study assessments, multiplied by 100.
Time frame: Baseline (randomization) through Month 12
Adherence to Study Procedures
Percentage of required study procedures completed according to the study protocol among enrolled participants.
Time frame: Baseline (randomization) through Month 12
Participant Acceptability of the Comprehensive Management Strategy
Acceptability and satisfaction with the comprehensive biomarker-guided management strategy will be assessed among participants using an Acceptability and Satisfaction Questionnaire.
Time frame: Baseline (randomization) through Month 12
Clinician Acceptability of the Comprehensive Management Strategy
Acceptability and satisfaction with the comprehensive biomarker-guided management strategy will be assessed among participating clinicians using an Acceptability and Satisfaction Questionnaire.
Time frame: Baseline (randomization) through Month 12
Plan to share: Undecided — The study team has not yet determined whether IPD will be shared with other researchers. Any future data-sharing plans will be developed in accordance with applicable ethics approvals, participant consent, and institutional policies.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Oct 2028, 22 months later.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 22 months is close to that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Dec 2028 → Oct 2028 and completion Mar 2029 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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