Helping Olfaction and Nutrition On Renal Replacement
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Smell Identification Test Score at 6 Weeks
Study Overview
Brief Summary
This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.
Detailed Description
Malnutrition and cachexia are prevalent in end stage renal disease (ESRD) patients and are associated with increased morbidity and mortality. Food aversion is a major contributor to anorexia and malnutrition in ESRD and it also impacts the quality of life. Olfactory dysfunction has been shown to contribute to food aversion in ESRD patients. Since up to 80% of a meal's flavor is attributed to olfactory input, loss or alteration of smell leads to loss or alteration of taste in ESRD patients and at present there are no effective therapies to treat smell and/or taste disorders in ESRD patients.
In patients with other causes of olfactory dysfunction such as congenital hyposmia and traumatic brain injury, intranasal theophylline has been shown to be effective in improving olfactory defects via increasing nasal mucus levels of cAMP and cGMP, second messengers critical for optimal smell sensation. However, the efficacy of nasal theophylline to improve olfaction in ESRD patients has not been investigated and the effects of nasal theophylline treatment on the nutritional parameters are unknown in ESRD patients.
Aim: To examine the efficacy and safety of nasal theophylline treatment to improve olfaction and nutrition in ESRD patients
Hypothesis
Nasal theophylline treatment improves olfaction and nutrition in ESRD patients with olfactory defects by via increasing intracellular cAMP and cGMP levels.
A previous pilot clinical trial demonstrated that intranasal theophylline is safe and effective in improving olfactory deficits in congenital hyposmia and traumatic brain injury, however, it has not been examined in ESRD patients. The investigators will conduct a pilot single arm open-label clinical trial (n=20) of 6 weeks duration to examine the efficacy and safety of nasal theophylline in hemodialysis-dependent ESRD patients with olfactory defects. The investigators will examine whether nasal theophylline improves olfaction and nutritional status in trial participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nasal theophylline
20 μg intranasal theophylline (theophylline methylpropyl paraben in a 0.4-mL saline solution) once daily (in the morning) into each naris for a total of 6 weeks
Intervention: Theophylline (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Smell Identification Test Score at 6 Weeks
Time Frame: Baseline and every 2 weeks for 6 weeks
Smell identification test is a validated 40-item scratch and sniff smell identification test that was administered by study investigators. Scores on this test scale range between 0 (minimum) to 40 (maximum). Higher score indicates better ability for smell identification. Total scores are reported on this scale (no sub-scales). The unit is score on this scale.
Change From Baseline in Smell Threshold Test Score at 6 Weeks
Time Frame: Baseline and every 2 weeks for 6 weeks
This test determined the lowest concentration of an odor compound that is perceivable by study participants. Scores on this test scale range between -2 and -10. Higher score indicates higher smell detection threshold (i.e. worse ability to smell). Total scores are reported on this scale (no sub-scales). The unit is score on this scale.
Secondary Outcomes
- Change From Baseline in Plasma Theophylline Level at 6 Weeks(Baseline and every 2 weeks for 6 weeks)
Investigators
Sagar U. Nigwekar, MD, MMSc
Assistant in Medicine
Massachusetts General Hospital