Asthma Trial, Recruiting NCT06136091 Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Condition: Asthma
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Asthma Trial, Recruiting

NCT06136091
Recruiting Not Applicable

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:

  • The participant (and/or their parent or guardian, if applicable) must be able to understand and agree to take part in the study.
  • People who live in one of the specific neighbourhoods (census tracts) pre-selected for this study, as outlined in the study's operating guidelines.
  • People who do not live in one of those specific neighbourhoods but live within the broader metropolitan area defined by the Office of Management and Budget and have government-funded health insurance may also be considered (confirm with trial site).
  • People who have been diagnosed with asthma more than 1 year before joining the study — or, if diagnosed within the last year, can confirm their breathing symptoms started more than 1 year ago (asthma group).
  • People who have never been diagnosed with asthma (non-asthma group).
  • People in the asthma group who need at least a moderate level of asthma treatment (called "Step 2 therapy") at the time of joining (confirm with trial site).
  • People in the non-asthma group who have not used any asthma medications in the past year.
  • People who are able to complete a standard breathing test (called spirometry) that meets specific quality guidelines before joining.
  • People who have current health insurance that includes prescription drug coverage at the time of joining.
  • The participant or their parent/guardian must own a smartphone that works with the study's digital reporting app (Medidata Patient Cloud) and be willing to download it.

Who may not be able to join:

  • People whose parent or guardian is unable or unwilling to provide written consent or follow the study requirements (where applicable).
  • People who have other medical conditions that would require them to take steroid tablets or other immune-suppressing medicines during the study.
  • People who are currently receiving allergy immunotherapy (such as allergy shots or drops).
  • People who are currently receiving, or have received within the past 3 months, a biologic therapy (a type of specialist medicine made from biological sources).
  • People whose asthma currently requires very high doses of multiple inhaled medicines, or who need to take steroid tablets daily or every other day for more than 14 days at the time of joining (confirm with trial site for specific medicine thresholds).
  • People who are currently pregnant, breastfeeding, or planning to become pregnant during the study period. People who could become pregnant must either abstain from sex or use an accepted form of contraception throughout the study.
  • People who have a diagnosed lung condition other than asthma that is considered clinically significant.
  • People who currently have cancer, or whose cancer has been in remission for less than 12 months before joining.
  • People who have a known immune deficiency disease.
  • People who have taken part in another clinical trial or used an experimental drug within 4 weeks of joining.
  • People who have other health issues, physical exam findings, or test results that, in the opinion of the site investigator, could pose risks or affect the quality of the study.
  • People in the asthma group who are unwilling to have their asthma managed by the study's specialist doctor for the full duration of the study, or who are unwilling to adjust their asthma medicines in line with the study's guidelines.
  • People in the non-asthma group whose breathing test shows a significant improvement after using a reliever inhaler (confirm with trial site for the specific threshold).
  • People who have had a life-threatening asthma attack in the last 2 years requiring a breathing tube, mechanical ventilation, or resulting in a seizure caused by low oxygen — though reassessment may be possible as outlined in the study guidelines.

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 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
8 May 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Asthma disease activity measured by the number of exacerbations during the 12-month observation period

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: 21 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