Phase 4 Asthma Trial, Recruiting NCT06385236 Sponsor: University of California, San Diego Condition: Asthma
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Phase 4 Asthma Trial, Recruiting

NCT06385236
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing to follow all study procedures and are available for the full duration of the trial.
  • People whose asthma medications have not changed in the past 2 months, and who are currently using a medium or high dose inhaled corticosteroid (a preventer inhaler) AND at least one other asthma controller medication.
  • People whose asthma is currently poorly controlled or uncontrolled.
  • People with confirmed asthma, shown either by a test where their breathing improved after using a reliever inhaler, or by a past breathing test that showed airway sensitivity (confirm with trial site for exact test details).
  • People who agree to follow certain lifestyle guidelines for the length of the study.

Who may not be able to join:

  • People who are currently taking part in another interventional trial (such as a drug or diet study).
  • People who are currently using, or have used in the past 3 months, a biologic medication for asthma (a type of injectable treatment that targets specific parts of the immune system).
  • People who received a study medication in another clinical trial within the past 60 days, or within 5 half-lives of that medication — whichever period is longer.
  • People who have been diagnosed with another chronic lung condition alongside asthma, such as cystic fibrosis, COPD, chronic bronchitis, emphysema, severe spinal curvature affecting breathing, chest wall deformities affecting lung function, or a congenital (present from birth) lung or airway condition.
  • People who are currently receiving immune-modifying therapies for conditions other than asthma, including biologic medications that are also approved for asthma treatment.
  • People who are currently taking methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
  • People who are receiving allergen immunotherapy (allergy shots or similar treatment) but have not yet been on a stable maintenance dose for at least 3 months.
  • People who have had a bronchial thermoplasty procedure (a treatment using heat inside the airways) within the past 2 years.
  • People who were born before 30 weeks of pregnancy (premature birth before 30 weeks).
  • People with poorly controlled high blood pressure, defined as a top reading above 160 or a bottom reading above 100 mmHg.
  • People with a history of cancer in the last 5 years, except for certain non-melanoma skin cancers.
  • People with a significant smoking history — specifically, those under 45 who have smoked 5 or more pack-years, or those 45 and older who have smoked 10 or more pack-years (confirm with trial site what "pack-years" means in this context).
  • People who have used any inhaled substance (other than prescribed medications) more than once a month in the past year.
  • People with a history of substance abuse within the last year.
  • People who are unwilling to use medically acceptable contraception or abstain from sex during the study, as well as people who are currently pregnant or breastfeeding.
  • People who require daily oral or injected corticosteroid (steroid) medication at the time of screening.
  • People who have had a respiratory infection within 1 month of the screening visit.
  • People who required a breathing tube (intubation) due to asthma in the past 12 months.
  • People who have any significant abnormal results from health checks, blood tests, heart tracings, or physical exams during the lead-in period, which the trial doctor believes could put the person at risk or affect the study results.
  • People with a BMI (body mass index) over 38.
  • People who are allergic to any of the medications, biologics, or substances used in this study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Kelan Tantisira, MD, University of California, San Diego

Phone: 520-626-9552

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
19 February 2024
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Predicting asthma outcomes and therapeutic responses; Responses to the biologic therapies at the single cell level; Unique asthma subgroups clinical and molecular endotype approaches

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov