AsthmaOPTIMALNCT04648761
Individualized Titration of Biologics in Severe Asthma
A study testing OPTIMAL algorithm in people with Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
OPTIMAL is a non-inferiority, open label randomized clinical trial thats investigates a titration algorithm for anti IL 5 biologics in severe asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- OPTIMAL algorithm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 1 Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed written consent
- Age > 18 years
- Correct asthma diagnosis as judged by (sub)-investigator
- Treatment with anti-IL5/IL5r for 12 months or longer
- Treatment with the same biologic drug in the last 12 months
- No exacerbations requiring OCS in the last 12 months
Show all 10Show fewer
- Blood eosinophils < 0.30 in the last 12 months
- No daily OCS for more than 3 days in the last 12 months with asthma as indication
- Correct inhalation technique for using regular inhalers
- Acceptable adherence to ICS (according to FMK as judged by (sub)-investigator)
Who cannot join
- - Pregnant or breastfeeding females
- Lack of effective contraception in women of childbearing potential who are sexually active with a non-sterilized male partner. Women of childbearing potential are defined as those who are not surgically sterile (e.g. bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Effective contraception is defined as intrauterine device (hormonal or non-hormonal), sexual abstinence, bilateral tubal occlusion, combined (estrogen and progesterone) hormonal contraception (oral, intravaginal and transdermal) and progesterone-only hormonal contraception (oral, injectable and implantable).
- Previous medical history or evidence of an uncontrolled intercurrent illness such as but not limited to (e.g. Autoimmune disease, immunodeficiency, immunosuppression, malignant neoplastic conditions with current relevance) that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the algorithm or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidaemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to inclusion are eligible.
- Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the algorithm or interpretation of subject safety or study results (eg. chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis polyangitiis, alpha-1-antitrypsin deficiency, Wegeners granulomatosis, Sarcoidosis).
- Any clinically relevant abnormal findings in haematology or clinical chemistry (laboratory results from Visit 0), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Show all 9Show fewer
- History of chronic alcohol- or drug abuse 12 months prior to inclusion
- Concurrent enrolment in another clinical study involving an investigational treatment.
- Use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to inclusion and during the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory Research Unit, Med. Clinic I, Bispebjerg Hospital, Bispebjerg Bakke 23
Copenhagen, NV, 2400
About this study
Official title: OPTIMAL - Individualized Titration of Biologics in Severe Asthma
OPTIMAL is a non-inferiority, open label randomized clinical trial thats investigates a titration algorithm for anti IL 5 biologics in severe asthma.
- Conditions
- Asthma
- Being tested
- OPTIMAL algorithm
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMAL algorithmBiological
The OPTIMAL algorithm titrates anti IL 5 treatment by addjusting the intervals between injections by FEV1, blood eosinophils and exacerbations.
| Study group | Role | What they receive |
|---|---|---|
| OPTIMAL group | Experimental | This group will have their anti IL 5 biologics titrated by OPTIMAL algorithm Receives: Biological: OPTIMAL algorithm |
| Control group | No intervention | This group will continue their treatment with anti IL 5 biologics unchanged |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of proportions of patients with exacerbations aften one year in each group
Measured: one year
Secondary outcomes (1)
Proportion of patients on reduced dose of biologics at the end of trial
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2023 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will have their biological treatment titrated via the OPTIMAL algorithm and a control group will continue their biological treatment unchanged.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celeste Porsbjerg, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648761
- Sponsor's protocol ID
- OPTIMAL
- Acronym
- OPTIMAL
- Status last verified
- Jan 2023
- First submitted
- 24 Nov 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMAL - Individualized Titration of Biologics in Severe Asthma
- ClinicalTrials.gov ID
- NCT04648761
- Acronym / sponsor ID
- OPTIMAL / OPTIMAL
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 2 Dec 2020 (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.
OPTIMAL is a non-inferiority, open label randomized clinical trial thats investigates a titration algorithm for anti IL 5 biologics in severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will have their biological treatment titrated via the OPTIMAL algorithm and a control group will continue their biological treatment unchanged.
| Arm | Type | Receives |
|---|---|---|
| OPTIMAL group | Experimental | Biological: OPTIMAL algorithmThis group will have their anti IL 5 biologics titrated by OPTIMAL algorithm |
| Control group | No intervention | –This group will continue their treatment with anti IL 5 biologics unchanged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed written consent
- Age > 18 years
- Correct asthma diagnosis as judged by (sub)-investigator
- Treatment with anti-IL5/IL5r for 12 months or longer
- Treatment with the same biologic drug in the last 12 months
Key exclusion criteria (9 listed)
- - Pregnant or breastfeeding females
- Lack of effective contraception in women of childbearing potential who are sexually active with a non-sterilized male partner. Women of childbearing potential are defined as those who are not surgically sterile (e.g. bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Effective contraception is defined as intrauterine device (hormonal or non-hormonal), sexual abstinence, bilateral tubal occlusion, combined (estrogen and progesterone) hormonal contraception (oral, intravaginal and transdermal) and progesterone-only hormonal contraception (oral, injectable and implantable).
- Previous medical history or evidence of an uncontrolled intercurrent illness such as but not limited to (e.g. Autoimmune disease, immunodeficiency, immunosuppression, malignant neoplastic conditions with current relevance) that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the algorithm or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidaemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to inclusion are eligible.
- Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the algorithm or interpretation of subject safety or study results (eg. chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis polyangitiis, alpha-1-antitrypsin deficiency, Wegeners granulomatosis, Sarcoidosis).
- Any clinically relevant abnormal findings in haematology or clinical chemistry (laboratory results from Visit 0), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMAL algorithmThe OPTIMAL algorithm titrates anti IL 5 treatment by addjusting the intervals between injections by FEV1, blood eosinophils and exacerbations. | Biological | OPTIMAL group |
Primary outcome
Comparison of proportions of patients with exacerbations aften one year in each group
Time frame: one year
1 secondary outcome
Proportion of patients on reduced dose of biologics at the end of trial
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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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?
A study testing OPTIMAL algorithm in people with Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. 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 Denmark. 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?
Results are not available in the source record.
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?
Comparison of proportions of patients with exacerbations aften one year in each group (time frame: one year). 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 18 Jan 2023.