150 Participants Needed

CYR-064 for Loss of Smell

Recruiting at 14 trial locations
KG
RG
DY
MT
Overseen ByMas Takashima, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Cyrano Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment called CYR-064 to see if it is safe and works well. About 150 people will take part in the study. The trial will last several months, including initial checks, treatment, and follow-up periods.

Will I have to stop taking my current medications?

The trial requires participants to stop using any over-the-counter or prescription medications administered intranasally, except for nasal saline. Other medications may need to be stopped if the investigator believes they could affect safety or compliance with the study.

Is theophylline safe for human use?

Theophylline has been used in various treatments and is generally safe, but it can cause side effects like stomach issues, heart problems, and nervous system effects in some people. The risk of side effects is higher with larger doses, but smoking seems to reduce these risks.12345

How is the drug CYR-064 (Theophylline) unique in treating loss of smell?

CYR-064 (Theophylline) is unique because it is a phosphodiesterase inhibitor that can improve smell function by increasing levels of certain molecules (cAMP and cGMP) in nasal mucus, which are often low in people with smell loss. Unlike other treatments, it can be administered both orally and intranasally, offering flexibility in treatment options.13467

What data supports the effectiveness of the drug CYR-064 for loss of smell?

Research shows that theophylline, a component of CYR-064, improved smell function in over 50% of patients with smell loss (hyposmia) in several studies. This suggests that theophylline may help restore the sense of smell in some people.13478

Who Is on the Research Team?

MT

Mas Takashima, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-65 who've lost their sense of smell but don't have any nasal blockages or diseases causing it. They must be able to take the study drug themselves and follow the trial's procedures.

Inclusion Criteria

Endoscopy of the nasal cavity reveals no structural or pathologic issues that would impede delivery of study drug to olfactory receptors, as concluded by the Investigator.
I can take the study drug as directed and follow the study's schedule.
You have had a CT scan of your nose within the past two years with no identifiable structural or pathologic issue that would prevent study drug from reaching olfactory receptors.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either CYR-064 or placebo nasal solution twice a day for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • CYR-064
Trial Overview The trial tests CYR-064 against a placebo to see if it's safe and works for people with reduced sense of smell. Participants are randomly chosen to receive either CYR-064 or a fake drug, without knowing which one they get.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CYR-064 dose 2Experimental Treatment1 Intervention
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
Group II: CYR-064 dose 1Active Control1 Intervention
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
Group III: PlaceboPlacebo Group1 Intervention
Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cyrano Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
150+

Published Research Related to This Trial

In a study of 312 patients with hyposmia, oral treatment with theophylline improved smell function in over 50% of participants, indicating its potential efficacy as a treatment for smell disorders.
Responders to theophylline treatment had higher levels of nasal mucus cAMP and cGMP compared to nonresponders, suggesting that these biomarkers may help predict which patients are more likely to benefit from theophylline therapy.
Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides.Henkin, RI., Velicu, I., Schmidt, L.[2018]
In a study of 312 patients with smell loss (hyposmia), theophylline treatment led to significant improvements in smell function, with 50.3% of patients reporting subjective improvement and 21.7% achieving normal smell function.
Higher doses of theophylline (600-800 mg) were more effective than lower doses, and improvements in smell function persisted as long as treatment was maintained, with follow-up periods ranging from 6 to 72 months.
An open-label controlled trial of theophylline for treatment of patients with hyposmia.Henkin, RI., Velicu, I., Schmidt, L.[2013]
In a study involving 22 adults with post-viral olfactory dysfunction, intranasal theophylline saline irrigation was found to be safe, with no adverse events reported and undetectable serum theophylline levels in most patients.
While slightly more patients in the theophylline group reported improved smell compared to placebo, the differences were not clinically meaningful, indicating that larger trials or dose adjustments may be necessary to achieve significant treatment effects.
Smell Changes and Efficacy of Nasal Theophylline (SCENT) irrigation: A randomized controlled trial for treatment of post-viral olfactory dysfunction.Lee, JJ., Peterson, AM., Kallogjeri, D., et al.[2023]

Citations

Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. [2018]
An open-label controlled trial of theophylline for treatment of patients with hyposmia. [2013]
Smell Changes and Efficacy of Nasal Theophylline (SCENT) irrigation: A randomized controlled trial for treatment of post-viral olfactory dysfunction. [2023]
Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. [2013]
Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. [2012]
Clinical toxocity of theophylline in relation to cigarette smoking. A report from the Boston Collaborative Drug Surveillance Program. [2019]
Safety and efficacy of once-daily Uniphyl tablets compared with twice-daily Theo-Dur tablets in elderly patients with chronic airflow obstruction. [2019]
Theophylline induces changes in the electro-olfactogram of the mouse. [2021]
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