Theophylline Nasal Spray for Loss of Smell

Overseen By Brigette S Vaughan, MSN, APRN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Nebraska

Must not be taking: Intranasal medications, Theophylline

Disqualifiers: Substance use disorder, Active malignancy, Chronic sinusitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn if intranasal theophylline (CYR-064) improves sense of smell in participants with hyposmia or anosmia related to the onset of Parkinson's Disease. Fifteen adults, age 19-80, years will participate for about 32 weeks. They will use the study nasal spray for 24 weeks. The nasal spray is given as 2 sprays to each side of the nose twice per day. They will be seen every 2 weeks during the first month of treatment, followed by monthly in-person visits. Tests about memory, Parkinson's Disease symptoms, and ability to detect and identify smells will be completed. Participants are monitored for any side effects.

Research Team

Mara Seier, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for adults aged 19-80 with Parkinson's Disease who have lost their sense of smell or have a reduced ability to smell. Participants will use the study nasal spray twice daily and attend regular check-ups.

Inclusion Criteria

Able to provide written informed consent

Hyposmia defined as ≤5 on the NRS-11 smell scale (scale of 0-10; 10 indicating normal sense of smell, 0 indicating no sense of smell)

A MOCA score >24

Exclusion Criteria

I have visible signs or symptoms of a chronic sinus or respiratory infection.

I need nasal sprays or drops for my severe allergy symptoms.

My main issue is distorted smell perception.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intranasal theophylline (CYR-064) nasal spray for 24 weeks to improve sense of smell

24 weeks

4 visits (in-person) every 2 weeks during the first month, followed by monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up phone call

Treatment Details

Interventions

• Theophylline Nasal Spray

Trial Overview The trial tests if CYR-064, a theophylline-based nasal spray, can improve the sense of smell in those affected by hyposmia or anosmia due to Parkinson's Disease. It involves using the spray over a period of 24 weeks with follow-up visits.

Participant Groups

Group I: Intranasal Theophylline Experimental Treatment 1 Intervention

Theophylline Intranasal Spray strength 3.1mg/mL, providing a per spray dose of 140 microgram and total daily dose of 1120 microgram per day (2 sprays per naris BID). Intervention is self-administered.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+