Evaluation of Omalizumab Dose Adjustment in Patients with Severe Allergic Asthma: A Clinical Trial on Dose Reduction and Administration Frequency

The primary objective of this study is to evaluate whether a 50% dose reduction of **omalizumab** in patients with allergic severe asthma can maintain clinical stability. This is assessed by monitoring the absence of asthma exacerbations, quality of life, and lung function. The clinical relevance of this objective lies in potentially optimizing treatment regimens, reducing medication burden, and minimizing side effects while maintaining effective asthma control.

The clinical trial involves participants diagnosed with **asthma**, specifically focusing on individuals aged between 18 and 80 years. Both male and female subjects are included in the study, and the population is not considered vulnerable. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population require participants to have maintained a 100% adherence to omalizumab treatment, an Asthma Control Test (ACT) score of 19 or higher, and stable lung function with a Forced Expiratory Volume in 1 second (FEV1) greater than 80%, or the best possible value for those with previous lung function deterioration. Participants must not have used oral corticosteroids, nor have had emergency visits or hospital admissions in the six months prior to the study. The trial does not impose specific lifestyle considerations such as diet or physical activity. Participants are required to attend in-person or telephonic visits and must provide informed consent, with the option for a legal tutor to authorize participation if necessary.

The clinical trial is designed to evaluate the efficacy of a 50% dose reduction of **omalizumab** in patients with allergic severe asthma, assessing whether clinical stability can be maintained. This study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the reduced dose, thus minimizing bias. The trial is expected to span approximately four years, with an estimated end date of March 24, 2026.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on specific criteria, such as age between 18 and 80 years, adherence to omalizumab, and stable lung function. Following the screening, participants will attend regular follow-up visits, either in-person or telephonically, to monitor their health status and adherence to the study protocol. The end-of-study visit will conclude the trial, where final assessments of clinical stability, quality of life, and lung function will be conducted.

The expected length of participant involvement is up to 12 months, depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include non-compliance with the treatment regimen, significant adverse events, or withdrawal of consent. The trial aims to provide valuable insights into the potential for dose reduction in maintaining asthma control, contributing to optimized therapeutic strategies for patients with allergic severe asthma.

The clinical trial involves the administration of **omalizumab**, marketed under the name Xolair, in two different formulations. The first formulation is Xolair 75 mg, presented as a **solution for injection** in a pre-filled syringe. This formulation is intended for **cutaneous use**. The maximum daily dose is 600 mg, with a total maximum dose of 600 mg over a treatment period of up to 1 month. The active substance, omalizumab, is a protein of non-human origin, specifically designed to target and neutralize immunoglobulin E (IgE). The administration frequency and dosage adjustments are determined based on the patient's clinical response and the study protocol.

The second formulation used in the trial is Xolair 150 mg, also a **solution for injection** in a pre-filled syringe. This formulation is administered via **subcutaneous injection**. Similar to the 75 mg formulation, the maximum daily dose is 600 mg, with a total maximum dose of 600 mg, but the treatment period extends up to 12 months. The active substance remains omalizumab, and the administration schedule is adjusted according to the patient's response to treatment. Both formulations are produced by Novartis Europharm Limited and are not designated as pediatric formulations. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol.

In addition to the experimental treatments, the study may include standard-of-care therapy as a non-experimental treatment, depending on the patient's condition and the investigator's discretion. No placebo or comparator treatment is specified in the trial documentation. The primary objective of the study is to evaluate the efficacy of a 50% dose reduction of omalizumab in maintaining clinical stability in patients with allergic severe asthma, as measured by the absence of exacerbations, quality of life, and lung function.

The efficacy of the clinical trial will be assessed by evaluating whether a 50% dose reduction of **omalizumab** in patients with allergic asthma maintains clinical stability. The primary endpoints for efficacy assessment include the absence of asthma crises, quality of life, and lung function. These parameters will be measured to determine if the reduced dosage can sustain the same level of disease control as the full dosage.

Data collection will involve monitoring the lack of emergency visits or hospital admissions, adherence to omalizumab, and maintaining a stable Forced Expiratory Volume in 1 second (FEV1) greater than 80% or the best achievable value for those with prior lung function deterioration. The assessment will also consider the absence of oral corticosteroid use. The trial will ensure that patients meet these criteria over a six-month period before the dose reduction is implemented. The study will utilize both in-person and telephonic visits to gather patient-reported outcomes and clinical data.