Orange, CANCT06023589Now EnrollingIRB Ready

Severe Asthma Clinical Trial in Orange, CA

Access cutting-edge severe asthma treatment through this phase 3 clinical trial at a research site in Orange. Study-provided care at no cost to qualified participants.

Sponsored by AstraZeneca

Quick Self-Assessment

See if you qualify for this Orange location

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Expert Care in Orange

Access severe asthma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related severe asthma treatment provided free

Apply for This Orange Location

Check if you qualify for this severe asthma clinical trial in Orange, CA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Orange

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Orange site if eligible
  4. 4Begin participation

About This Severe Asthma Study in Orange

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

Sponsor: AstraZeneca

Who Can Participate

Inclusion Criteria

Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.
Participants must be 5 to \< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.
Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
Supportive evidence of asthma as documented by one of the following:
Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2. If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:
Post-BD responsiveness of FEV1 ≥ 10%.
Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
PEF average daily diurnal variability \> 13% over a 2-week period.
Variability of FEV1 ≥ 12% between any two clinical visits.
Positive exercise challenge test (defined as a fall in FEV1 of \> 12%).
FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.
Pre-BD FEV1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.
Evidence of uncontrolled asthma, with at least 1 of the below criteria:
ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.
Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period.
Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.
Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.
Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

Exclusion Criteria

History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.
Change in ICS dose within 1 month prior to Visit 1.
History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orange?

Yes, this clinical trial (NCT06023589) has an active research site in Orange, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Severe Asthma Treatment Options in Orange, CA

If you're searching for severe asthma treatment options in Orange, CA, this clinical trial (NCT06023589) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orange research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced severe asthma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all severe asthma clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Orange, CA