Safety and Efficacy of CYR-064 Theophylline Nasal Spray for the Treatment of Post-Viral Hyposmia

Clinical Trial Title

A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine the Safety and Efficacy of CYR-064 Theophylline Nasal Spray for the Treatment of Post-Viral Hyposmia

National Clinical Trial Number:

NCT06019000

Contact Information

Mahendrakumar Shah

Clinical Trial Protocol Description:

The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064.

The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are male or female 18-65 years of age.
  • Have endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia.
  • Have had CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years).
  • Are willing and able to self-administer the study drug.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve. 
  • Have a history of surgery that led to hyposmia. 
  • Have concomitant medical conditions.
  • Have current symptoms or signs of an acute respiratory viral illness at Screening or Baseline. 
  • General Exclusions: Any female who is pregnant, planning to become pregnant during the study, or who is lactating.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Pete Batra, MD, FACS

Contact Information

Mahendrakumar Shah

Clinical Trial Location

RUSH University Medical Center

Location

RUSH University Medical Center

1620 W Harrison St
Chicago, IL 60612

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