Helping Olfaction and Nutrition On Renal Replacement

NCT02479451 | Completed Phase 2 Results DMC

• 1 other identifier: 2015P001231
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.

Conditions

End Stage Renal Disease; Olfactory Disorders

Keywords

End stage renal disease; Olfaction; Dialysis; Hemodialysis; Malnutrition

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Smell Identification Test Score at 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.

  Baseline and every 2 weeks for 6 weeks

• Change From Baseline in Smell Threshold Test Score at 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.

  Baseline and every 2 weeks for 6 weeks

Secondary Outcomes (1)

• Change From Baseline in Plasma Theophylline Level at 6 Weeks

  Baseline and every 2 weeks for 6 weeks

Study Arms (1)

Nasal theophylline

EXPERIMENTAL

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

Drug: Theophylline

Interventions

Theophylline DRUG

The study medication will be provided by Foundation Care.

Nasal theophylline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 19359985 BACKGROUND

• 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.

  PMID: 23165381 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Anosmia; Malnutrition

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sagar Nigwekar
• Organization: Mass General Hospital

sagarnigs@gmail.com

5857298636

Study Officials

• Sagar U Nigwekar, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Medicine

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 24, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-11

Locations

US (1)