Phase 4 Asthma Trial, Recruiting NCT04380038 Sponsor: University of Virginia Condition: Asthma
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Phase 4 Asthma Trial, Recruiting

NCT04380038
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:

  • Adults between 18 and 40 years old
  • People who have been diagnosed with asthma by a doctor for at least 6 months
  • People whose asthma has been well controlled (scoring 20 or above on the Asthma Control Test) for the 6 months before joining the trial
  • People whose lung function test shows their lungs are working at more than 80% of the expected level for someone their age and size
  • People whose asthma is managed with a reliever inhaler (albuterol) alone, or with a reliever inhaler plus a low-to-medium dose steroid inhaler, with or without other controller medicines — and who are not using any anti-inflammatory medicines for nose or sinus conditions
  • People who test positive on a methacholine challenge test, which checks how sensitive the airways are (confirm with trial site)
  • People who have a raised level of certain immune cells (eosinophils) in their blood, or a raised level of a marker of airway inflammation measured in their breath (FeNO) (confirm with trial site)
  • People who test negative for certain antibodies to two specific cold viruses (HRV 16 and HRV 39) (confirm with trial site)
  • People who are willing and able to attend clinic visits and follow study procedures
  • People who are able to give their own signed consent to take part
  • People who are able to understand and fill in study questionnaires

Who may not be able to join:

  • People who currently smoke, or who have smoked regularly for 10 or more years with a heavy smoking history (more than 10 pack-years)
  • People with a history or signs of COPD or any other significant lung disease
  • People with a known allergy to any ingredient in the study treatment
  • People who have received a biologic therapy for asthma (including dupilumab) in the last 3 months
  • People who have used antiviral, immune-suppressing, or immune-modifying treatments in the last 3 months
  • People who use any inhaled nasal sprays
  • People who have had an upper or lower respiratory tract infection in the last 6 weeks
  • People who have had an asthma flare-up in the last 6 weeks
  • People who have ever had a serious asthma attack that required a visit to an emergency department, being placed on a breathing machine, or a hospital stay
  • People who have had an asthma flare-up in the past 3 years that required an unplanned doctor's visit or a course of steroid tablets
  • Members of the clinical trial team at the study site, or their immediate family members
  • People who are pregnant or breastfeeding
  • Women who could become pregnant and are unwilling to use highly effective contraception before, during, and for at least 4 months after the study treatment. Accepted methods include hormonal contraception (pill, patch, ring, injection, or implant) started at least two menstrual cycles before the study, an intrauterine device (IUD or IUS), surgical sterilisation (tubal ligation), a partner who has had a vasectomy, or complete abstinence from heterosexual intercourse throughout the study period. Note: certain methods such as condoms alone, spermicides, the rhythm method, and withdrawal are not considered acceptable (confirm details with trial site)

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 27 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: Larry Borish, MD, University of Virginia

Phone: 4349817599

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
1 May 2022
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in interleukin-25 transcript expression post-rhinovirus inoculation

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: 27 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