MedTrace Logo

Smell Changes & Efficacy of Nasal Theophylline

NCT03990766 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-03-31

Study results available
· View outcomes & findings →

Summary

This study evaluates the efficacy and safety of nasal theophylline irrigation in treating smell loss related to a viral respiratory infection. Half the participants will undergo nasal theophylline irrigation treatment while the other half will undergo placebo nasal irrigation with saline alone. All participants will have their sense of smell tested before and after 6 weeks of treatment. All participants will also be regularly asked about any potential side effects related to treatment. In addition, the first 10 participants will have their blood drawn to measure their theophylline level after 1 week of starting treatment to ensure it is not abnormally elevated.

Conditions

  • Olfactory Disorder
  • Anosmia
  • Viral Infection
  • Theophylline Causing Adverse Effects in Therapeutic Use
  • Smell Disorder

Interventions

DRUG

Theophylline

Theophylline delivered via high-volume, low-pressure nasal saline irrigation

DRUG

Saline Nasal

Lactose delivered via high-volume, low-pressure nasal saline irrigation

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-01-15
Completion
2021-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990766 on ClinicalTrials.gov