Individualized Titration of Biologics in Severe Asthma

Asthma Clinical Trial

— OPTIMAL  

Official title:

OPTIMAL - Individualized Titration of Biologics in Severe Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04648761
• Other study ID #: OPTIMAL
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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)

Exclusion Criteria:

• - 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.

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• OPTIMAL algorithm
The OPTIMAL algorithm titrates anti IL 5 treatment by addjusting the intervals between injections by FEV1, blood eosinophils and exacerbations.

Locations

Country	Name	City	State
Denmark	Respiratory Research Unit, Med. Clinic I, Bispebjerg Hospital, Bispebjerg Bakke 23	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of proportions of patients with exacerbations aften one year in each group		one year
Secondary	Proportion of patients on reduced dose of biologics at the end of trial		One year