Phase 2
N=7
Helping Olfaction and Nutrition On Renal Replacement
End Stage Renal Disease · Olfactory Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02479451 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Change From Baseline in Smell Identification Test Score at 6 Weeks — 4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Theophylline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Smell Identification Test Score at 6 Weeks |
4 | — |
| PRIMARY Change From Baseline in Smell Threshold Test Score at 6 Weeks |
-1 | — |
| SECONDARY Change From Baseline in Plasma Theophylline Level at 6 Weeks |
— | — |
Summary
This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.
Eligibility Criteria
Inclusion Criteria
- ESRD requiring chronic outpatient hemodialysis
- Able to provide written consent
- Defects in smell identification and/or smell threshold detection as measured by "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and Smell Threshold Test
Exclusion Criteria
- Prior allergic reaction to theophylline
- Patients currently treated with theophylline for clinical indication
- Pregnancy or lactation
- ESRD patients on peritoneal dialysis
- Patients hospitalized at the time of study enrollment
Data sourced from ClinicalTrials.gov (NCT02479451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.