Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Cont… (NCT06473779) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.
United States, Argentina, Belgium326 participantsStarted 2024-09-30
Plain-language summary
The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma..
Study details include:
1. The study duration will be up to 72 weeks.
2. The treatment duration will be up to 68 weeks.
3. The visit frequency will be once every 4 weeks (Q4W).
Who can participate
Age range
12 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses for patients who are at or over the age of majority (as per local law). For patients who are less than the age of majority, in addition to providing their informed consent, the patients' legally authorised representative must also provide their informed assent (Appendix A 3).
. Patients must be 12 to 80 years of age inclusive, at the time of signing the ICF.
. Documented medical record history for at least 12 months prior to Visit 1.
. Documented physician-diagnosed severe asthma within 10 years prior to Visit 1 (ie, severe asthma was not diagnosed more than 10 years prior) consisting of any of the following:
. FEV1 \> 12% reversibility, OR
. Evidence of airflow variability (to show that lung function is altered over time): FEV1 ≥ 400 mL variability over time, OR
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically about stepping down or reducing the Symbicort maintenance dose while staying on tezepelumab — am I currently on tezepelumab, or would I need to already be taking it to even be considered for something like this?
2Since this is a Phase 3 trial, what does that mean for what's already known about tezepelumab's safety, and are there any risks specific to reducing my Symbicort dose during a step-down process that I should be aware of?
3The trial is active but no longer recruiting new patients — does that mean this specific study is closed to me, and if so, are there similar trials or approved pathways where stepping down my background asthma medication might be an option worth exploring?
4If the goal is to reduce my daily maintenance medication while keeping my asthma controlled, how would you know if my asthma is stable enough right now to even consider that kind of step-down approach, whether in a trial or outside of one?
5Are there standard-of-care options we should try first before looking at a trial like this, or does my current level of severe asthma make something like tezepelumab combined with a medication reduction a reasonable next conversation to have?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase.
. Challenge tests that are positive on one of the below:
. ACQ-5 ≥ 1.5 and \< 3.
Exclusion criteria
. Any clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral EOS counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
. Current smokers or patients with smoking history ≥ 10 pack-years and patients using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
. History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
. Tuberculosis requiring treatment within the 12 months prior to Visit 1.
. History of known immunodeficiency disorder including a positive human immunodeficiency virus test at Visit 1, or the patient taking antiretroviral medications as determined by medical history and/or patient's verbal report.
. Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia or inpatient status for \> 1 day during the conduct of the study.