OPT Study

JRCT ID: jRCTs031240091

Registered date:17/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe asthma
• Date of first enrollment: 28/05/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Switching from biologics other than omalizumab to omalizumab, questionnaire (questionnaire), peak flow test (when waking up in the morning and any time in the afternoon), special blood sampling (free IgE)

Outcome(s)

Primary Outcome

Proportion of patients achieving a partial response at 24 weeks after switching from other biologics to omalizumab treatment
The definition of partial response is to satisfy at least one of the following criteria A and 3 items, and at least one item of criteria B and 3 items.
Criterion A: Items reflecting treatment response (assessed at week 0 and week 24. )
1)The frequency of asthma symptom exacerbations (in the last 1 year) has decreased by more than 50% compared to when the current biologic treatment was started (at least 12 months ago).
2) No worsening of asthma symptoms is observed during the current period of use of biologics (at least 6 months or more). (ACQ-5<1.5)
3) Current use of biologics (at least 6 months or more) has reduced the use of OCS as maintenance therapy by more than 50% since the start of biologic therapy.

Criterion B: Items reflecting symptoms and respiratory instability (assessed at 24 weeks)
1)%FEV1<80%
2) You have asthma symptoms every day.
3) Asthma symptoms at night at least once a week

Secondary Outcome

After switching from other biologics to treatment with omalizumab, assess the following:
1)Percentage of patients who achieved clinical remission after 24 weeks of treatment with omalizumab
Definition of clinical remission:
Meets all of the following criteria:
1.Efficacy was confirmed by significant symptom improvement/disappearance in ACQ-5 (Asthma Control Questionnaire) (ACQ-5<1.5)
2.No worsening of asthma symptoms
3.No administration of systemic steroids
4.Respiratory function is stable (%FEV1>=80%)
2)Rate of change in %FEV1
3)Changes from baseline in asthma symptoms or asthma symptom scores collected using a paper asthma diary after 24 weeks of treatment with omalizumab
4)Change from baseline in overall evaluation of treatment efficacy after 24 weeks of treatment with omalizumab
5)Change from baseline in treatment satisfaction after 24 weeks of treatment with omalizumab

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have given their written consent to participate in this study before performing any protocol-related steps
2) Patients who have been diagnosed with bronchial asthma by a doctor at least 12 months before the date of consent acquisition (Visit 1)
3) Patients who are 18 years of age or older at the time of consent, regardless of gender
4) Patients who have been treated with high-dose ICS plus two or more types of maintenance therapy such as LABA or LAMA for more than 6 months.
5)Patients who have been receiving treatment with biological agents other than omalizumab for more than 6 months until the consent date.
6)Patients with the following conditions at the time of obtaining consent due to drugs currently being administered:
Patients who meet at least one item in Criterion A and at least one item in Criterion B below
(If at least one of the criteria A and B is satisfied, the eligibility is satisfied even if the test values of criteria A 1-3 and criteria B 1-3 are missing.)
Criterion A: Items reflecting treatment responsiveness
1.The frequency of exacerbations of asthma symptoms has decreased by 50% or more compared to when treatment with the currently used biological drug was started (at least 12 months ago).
2. No worsening of asthma symptoms is observed during the period of use of the current biological drug (at least 6 months or more). (ACQ-5<1.5)
3) Due to current use of the biologic (for at least 6 months), the amount of OCS used as maintenance therapy has decreased by 50% or more since the start of biologic therapy.
Criterion B: Items reflecting symptoms and instability of respiratory function
1.%FEV1<80%
2. I have asthma symptoms every day.
3. Having asthma symptoms at night at least once a week
7) Patients who conducted a year-round inhalation antigen test on Visit 1 (or up to Visit 2) and were found to be positive.
8) Patients with a total serum IgE level of 30 to 500 IU/mL as determined by blood sampling at Visit 1 (or up to Visit 2)
9) Patients whose dosing interval of omalizumab is every 4 weeks according to the dosing schedule calculated from body weight and total IgE level
Selection criteria 7), 8), and 9) will be checked at the time of Visit 2 to see if they meet the criteria.
Definition of exacerbation
1) Moderate asthma exacerbation
A condition that requires systemic steroid administration (hereinafter referred to as rescue treatment) for more than 3 days (hereinafter referred to as rescue treatment) at the time of outpatient or emergency department visit (less than 24 hours).
2) Severe asthma exacerbation
Exacerbation of any of the following
1. A condition that requires rescue treatment for more than 3 days and requires hospitalization.
2. Conditions that require rescue treatment for more than 3 days and emergency department visits (24 hours or more).
3. Death from asthma.
Emergency department visits for more than 24 hours are hospitalization.
A single dose of depot injection of corticosteroids is considered equivalent to a three-day course of systemic steroid drugs.

Exclude criteria

1) Patients receiving intermediate or low doses of ICS
2) Patients with high-dose ICS and a biological agent added to only one long-term control drug
3)Patients with a history of chronic lung disease (including comorbidities) other than asthma or heart failure
4) Women who are pregnant or breastfeeding
5) Patients with cancer/malignant tumor undergoing treatment
6) Patients who have previously been treated with omalizumab and who have concerns about safety, such as the occurrence of adverse events thought to be caused by omalizumab, or a history of hypersensitivity to the components of this drug.
7) Patients who are judged by the research physician to be inappropriate for this study
8) Patients whose dosing interval for omalizumab is every 2 weeks according to the dosing schedule calculated from body weight and total IgE level

Related Information

• Primary Sponsor: Masaki Katsunori
• Secondary Sponsor: Fukunaga Koichi,Novartis Pharma K.K.