Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2023-09-26
2025-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
CYR-064 dose 1 CYR-064 dose 2 Placebo
TREATMENT
QUADRUPLE
Study Groups
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CYR-064 dose 1
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
CYR-064
CYR-064 is a nasal solution.
CYR-064 dose 2
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
CYR-064
CYR-064 is a nasal solution.
Placebo
Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.
CYR-064
CYR-064 is a nasal solution.
Interventions
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CYR-064
CYR-064 is a nasal solution.
Eligibility Criteria
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Inclusion Criteria
* Male or female 18-70 years of age.
* Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
* CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
* Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol.
Exclusion Criteria
* History of surgery that led to hyposmia.
* Concomitant Medical Conditions
* Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline.
* Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records.
* Any active malignancy.
* Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data.
* History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator.
* History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps.
* Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS.
* Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline.
* Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up.
* Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data.
* General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating.
Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.
18 Years
70 Years
ALL
Yes
Sponsors
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Cyrano Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mas Takashima, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Colorado ENT & Allergy
Colorado Springs, Colorado, United States
ENTAAFL
Boca Raton, Florida, United States
ENTAAFL
Plantation, Florida, United States
ENTAAFL
Port Saint Lucie, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
KU Medical Center-University of Kansas
Kansas City, Kansas, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Centers for Advanced ENT
Baltimore, Maryland, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
Medical University of South Carolina-MUSC
Charleston, South Carolina, United States
Charleston ENT and Allergy
North Charleston, South Carolina, United States
Houston Methodist
Houston, Texas, United States
Ear Nose Throat & Allergy Associates
Puyallup, Washington, United States
Countries
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References
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Henkin RI, Levy LM, Fordyce A. Taste and smell function in chronic disease: a review of clinical and biochemical evaluations of taste and smell dysfunction in over 5000 patients at The Taste and Smell Clinic in Washington, DC. Am J Otolaryngol. 2013 Sep-Oct;34(5):477-89. doi: 10.1016/j.amjoto.2013.04.006. Epub 2013 Jun 2.
Henkin RI. Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. Ther Drug Monit. 2012 Apr;34(2):217-21. doi: 10.1097/FTD.0b013e3182492a20.
Henkin RI. Growth Factors in Olfaction. In: Preedy VR, editor. Handbook of Growth and Growth Monitoring in Health and Disease. New York, NY: Springer New York; 2012. p. 1417-36.
Henkin RI, Abdelmeguid M. Improved Smell and Taste Dysfunction with Intranasal Theophylline. Am J Otolaryngol Head Neck Surg. 2019;2(9):1070.
Henkin RI, Hosein S, Stateman WA, Knoppel AB, Abdelmeguid M. Improved smell function with increased nasal mucus sonic hedgehog in hyposmic patients after treatment with oral theophylline. Am J Otolaryngol. 2017 Mar-Apr;38(2):143-147. doi: 10.1016/j.amjoto.2016.11.010. Epub 2016 Nov 23.
Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342.
Henkin RI, Velicu I. cAMP and cGMP in nasal mucus related to severity of smell loss in patients with smell dysfunction. Clin Invest Med. 2008;31(2):E78-84. doi: 10.25011/cim.v31i2.3367.
Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97.
Henkin RI, Velicu I, Schmidt L. Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. Am J Med Sci. 2011 Jan;341(1):17-22. doi: 10.1097/MAJ.0b013e3181f1fdc8.
Other Identifiers
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CYR-064-01
Identifier Type: -
Identifier Source: org_study_id
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