Individualized Titration of Biologics in Severe Asthma

NCT04648761 | Unknown DMC

• 1 other identifier: OPTIMAL
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Comparison of proportions of patients with exacerbations aften one year in each group

  one year

Secondary Outcomes (1)

• Proportion of patients on reduced dose of biologics at the end of trial

  One year

Study Arms (2)

OPTIMAL group

EXPERIMENTAL

This group will have their anti IL 5 biologics titrated by OPTIMAL algorithm

Biological: OPTIMAL algorithm

Control group

NO INTERVENTION

This group will continue their treatment with anti IL 5 biologics unchanged

Interventions

OPTIMAL algorithm BIOLOGICAL

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

OPTIMAL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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).
• 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.
• Concurrent enrolment in another clinical study involving an investigational treatment.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Respiratory Research Unit, Med. Clinic I, Bispebjerg Hospital, Bispebjerg Bakke 23

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group will have their biological treatment titrated via the OPTIMAL algorithm and a control group will continue their biological treatment unchanged.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)