OPTIMAL - Individualized dosetitration of biological treatment in severe asthma

Phase 1

• Conditions: Severe asthma; MedDRA version: 21.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-003358-63-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-16
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Active smoking

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified