Study on Tezepelumab for Reducing Steroid Use in Adults with Steroid-Dependent Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Tezepelumab in adults with Oral Corticosteroid Dependent Asthma. This type of asthma requires ongoing treatment with oral corticosteroids, which are medications that help reduce inflammation in the airways. The study aims to see if Tezepelumab can help reduce the amount of oral corticosteroids needed while maintaining asthma control. Tezepelumab is given as a solution for injection using a pre-filled syringe.

Participants in the study will receive either Tezepelumab or a placebo, which is a substance with no active medication. The study will last for 28 weeks, during which participants will continue their usual asthma treatments, including inhaled corticosteroids and long-acting beta-agonists, alongside the study medication. The goal is to evaluate how well Tezepelumab works in reducing the need for oral corticosteroids and to assess its safety.

Throughout the study, participants will have regular check-ups to monitor their asthma symptoms and overall health. The study will also measure changes in lung function and asthma control, as well as any side effects experienced. This research is important for finding new ways to manage asthma that depends on oral corticosteroids, potentially improving the quality of life for those affected by this condition.

1 randomization and initial assessment

Upon joining the study, participants are randomly assigned to receive either the tezepelumab treatment or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

An initial assessment is conducted to establish baseline measurements, including lung function tests and blood tests. This helps in evaluating the effect of the treatment over time.

2 treatment administration

Participants receive a subcutaneous injection of either Tezspire 210 mg or a placebo every four weeks. The injection is administered using a pre-filled syringe.

The treatment period lasts for 28 weeks, during which participants continue their regular asthma medications, including oral corticosteroids (OCS), inhaled corticosteroids (ICS), and long-acting beta-agonists (LABA).

3 ongoing monitoring and assessments

Throughout the study, participants attend regular visits for monitoring and assessments. These visits include lung function tests, blood tests, and questionnaires to evaluate asthma control and quality of life.

Participants are required to maintain a daily diary to record medication use, asthma symptoms, and peak expiratory flow (PEF) measurements. Compliance with diary entries and medication use is monitored.

4 dose reduction phase

The primary goal of the study is to reduce the daily maintenance dose of oral corticosteroids while maintaining asthma control. Participants work with the study team to gradually reduce their OCS dose based on their asthma control and study guidelines.

The reduction in OCS dose is categorized into different levels, ranging from no change to a complete reduction, depending on the participant’s response to the treatment.

5 final assessment and follow-up

At the end of the 28-week treatment period, a final assessment is conducted to evaluate the overall effect of the treatment on asthma control and OCS dose reduction.

Participants may be asked to return for follow-up visits to monitor any long-term effects and to assess the presence of anti-drug antibodies (ADAs) at specified intervals.

Who Can Join the Study?

Participants must be between 18 and 80 years old.
Participants must have a history of at least one asthma worsening event in the last 24 months.
Participants must weigh at least 40 kg (about 88 pounds).
Both males and females can participate.
Women who can have children must have a negative pregnancy test at the start and before randomization.
Women who can have children and are sexually active with a male partner must use a highly effective birth control method during the study and for at least 16 weeks after the last dose of the study medication.
Participants must be able to give written consent to participate in the study.
Participants must agree to provide samples for optional genetic research.
Participants must complete a daily diary and morning peak flow measurements for at least 10 days before Visit 2.
Participants must take their asthma medications, including oral corticosteroids (OCS), inhaled corticosteroids (ICS), and long-acting beta-agonists (LABA), for at least 10 days before Visit 2.
Participants must have been on a stable dose of OCS for at least 2 weeks before randomization.
Participants must have been diagnosed with asthma by a doctor for at least 12 months before Visit 1.
Participants must have been prescribed medium- or high-dose ICS for at least 12 months before Visit 1.
Participants must have been prescribed LABA and high-dose ICS for at least 3 months before Visit 1. These can be in a combination product or separate inhalers.
Participants can use additional asthma medications like leukotriene receptor antagonists, theophylline, long-acting muscarinic antagonists, and chromones, if documented for at least 3 months before Visit 1.
Participants must have been taking OCS for asthma for at least 6 months before Visit 1 and on a stable dose of 7.5 to 30 mg of prednisone or prednisolone daily for at least one month before Visit 1.
Participants must have a morning lung function test result (FEV1) of less than 80% of the predicted normal value at Visit 1 or Visit 2.
Participants must show evidence of asthma through specific lung function tests, either in the past 60 months or at Visit 1, 2, or 3.
Participants must have a certain level of blood eosinophils, a type of white blood cell, at Visit 1 or documented within 12 months before Visit 1.
Participants must have at least 70% compliance with all asthma medication dosing during the OCS optimization phase.
Participants must have at least 70% compliance with daily diary completion and morning peak flow measurements during the OCS optimization phase.
Participants must have acceptable inhaler, peak flow meter, and spirometry techniques as judged by the investigator.

Who Cannot Join the Study?

Patients who do not have Oral Corticosteroid Dependent Asthma cannot participate. This means if you do not rely on oral corticosteroids to manage your asthma, you are not eligible.
Patients who are not taking high doses of ICS (inhaled corticosteroids) along with LABA (long-acting beta-agonists) are excluded. These are medications used to control asthma symptoms.
Patients who are not on a chronic treatment plan with OCS (oral corticosteroids) are not eligible. This means if you do not regularly take oral corticosteroids for your asthma, you cannot join the study.
Patients outside the specified age range are excluded. The study is only for certain age groups.
Patients who are not part of the specified clinical trial group cannot participate. This means only certain groups of people with specific characteristics are eligible.
Patients who are not considered part of a vulnerable population are excluded. This refers to groups of people who might need special protection or consideration in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Plicni alergo s.r.o.	Ostrava	Czechia

Other Sites

Site Name	City	Country
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
University Hospital Olomouc	Olomouc	Czechia
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.	Poznan	Poland
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
MUDr. Ilona Pavlisova s.r.o.	Miroslav	Czechia
Wlnctikbut Shbsozl Sbjx iov sdw Rngfkt w Crsrlnhmc Gpjwh Sxisjdfzzjjmdd Cskiitw Cibuna Pqqf	Checiny	Poland
Pssvgh Gbxcxvdh Glypxg Mdpxfch Kttnvork sspr	Sosnowiec	Poland
Oqtujuzvybex Ctvnjvt Mqwwpesp Awvv Otlmv Ctitvq Kwxqmjztf Ckjekz sbhn	Ostrowiec Swietokrzyski	Poland
Pajcanro Gupczhh Pjeondjoijhuwgk lofh Jtrduo Nljbomdeujdmc	Grudziadz	Poland
Eohb Cringjw Uusxb Mdyaflootw Epp Śckuesx	Rzeszow	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	04.08.2023
Poland	Not recruiting	04.08.2023

Trial locations

Investigated drugs:

Tezepelumab

Tezepelumab is a medication being studied for its ability to help reduce the use of oral corticosteroids in adults who have asthma that requires ongoing treatment with these steroids. It is being tested to see if it can effectively lower the amount of oral corticosteroids needed by patients who are also using high doses of inhaled corticosteroids and long-acting beta-agonists to manage their asthma.

Investigated diseases:

Asthma

Oral Corticosteroid Dependent Asthma – This form of asthma requires ongoing treatment with oral corticosteroids to manage symptoms and prevent exacerbations. It is characterized by chronic inflammation of the airways, leading to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The condition can vary in severity, with some individuals experiencing frequent asthma attacks that require additional medication. Over time, reliance on oral corticosteroids can lead to side effects, making it important to manage the condition effectively. The disease often requires a combination of medications to maintain control and reduce the need for oral corticosteroids. Regular monitoring and adjustments in treatment are typically necessary to manage symptoms and maintain quality of life.

Trial ID:

2023-504648-33-00

Protocol code:

SUNRISE

NCT ID:

NCT05398263

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tezepelumab for Reducing Steroid Use in Adults with Steroid-Dependent Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?