Phase 2 Asthma Trial, Recruiting NCT03885245 Sponsor: University of Colorado, Denver Condition: Asthma
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Phase 2 Asthma Trial, Recruiting

NCT03885245
Recruiting Phase 2

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:

  • You have agreed to participate and completed the consent process
  • Both men and women can join
  • You have been diagnosed with asthma by a doctor
  • You are able to do a breathing test (called spirometry) in a consistent, reliable way
  • Your breathing test results show your lungs are working at 50% or more of the expected level before using a bronchodilator (inhaler that opens the airways)
  • Your asthma diagnosis has been confirmed
  • People of all racial and ethnic backgrounds are welcome
  • Your Body Mass Index (BMI) is 30 or higher (considered obese range)
  • You have been regularly using an asthma inhaler containing a steroid (with or without a long-acting reliever medicine) for at least 1 month; being on biologic injections or infusions for asthma is also allowed
  • You have smoked no more than 10 pack-years in your lifetime and have not smoked in the last 3 months (confirm with trial site if unsure how pack-years are calculated)
  • You were 12 years old or older when you were first diagnosed with asthma
  • Your breathing airway inflammation test (called FeNO) shows a result of 30 or below
  • Your asthma symptoms are not fully controlled, based on a standard asthma symptom questionnaire score (confirm with trial site)

Who may not be able to join:

  • You have had a respiratory infection (such as a chest infection or cold affecting your airways) in the 4 weeks before your first study visit
  • You have taken a course of steroid tablets or injections for any reason in the 4 weeks before your first study visit (including one-off injections into a joint, which require a 4-week gap)
  • You visited an emergency room for asthma in the 4 weeks before your first study visit
  • You were admitted to an intensive care unit or put on a breathing machine due to asthma in the past year
  • You have had 3 or more serious asthma attacks requiring steroid tablets for more than 3 days in the past year
  • You needed steroid tablets for an asthma attack in the 4 weeks before your first study visit
  • You have chronic kidney failure
  • You test positive for nicotine or cannabis on the day of a procedure involving a camera in your airways (bronchoscopy)
  • You are pregnant or test positive on a pregnancy test at any point during the study
  • You have an allergy or intolerance to L-arginine or L-citrulline (confirm with trial site)
  • You are currently taking certain medications used for erectile dysfunction or chest pain called PDE5 inhibitors or oral mononitrates (confirm with trial site)
  • You have sleep apnea that is not being treated
  • You are currently taking part in another drug trial, have used an experimental drug in the last 30 days, or plan to join another drug trial during 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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Fernando Holguin, MD, MPH, University of Colorado Denver- Anschutz Medical Campus

Phone: 1 (844) 365-0852

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 2
Registry
ClinicalTrials.gov
Start date
1 October 2021
Est. completion
30 December 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Asthma Control Questionnaire; Change in Asthma Control Test

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: 28 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