Trial Outcomes & Findings for Helping Olfaction and Nutrition On Renal Replacement (NCT NCT02479451)

Last Updated: 2024-01-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Baseline and every 2 weeks for 6 weeks

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	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 Theophylline: The study medication will be provided by Foundation Care.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Helping Olfaction and Nutrition On Renal Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasal Theophylline n=7 Participants 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 Theophylline: The study medication will be provided by Foundation Care.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
ESRD	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and every 2 weeks for 6 weeks

Outcome measures

Outcome measures
Measure	Nasal Theophylline n=7 Participants 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 Theophylline: The study medication will be provided by Foundation Care.
Change From Baseline in Smell Identification Test Score at 6 Weeks	4 units on a scale Standard Error 2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nasal Theophylline n=7 Participants 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 Theophylline: The study medication will be provided by Foundation Care.
Change From Baseline in Smell Threshold Test Score at 6 Weeks	-1 change in score on the scale Standard Error 2

SECONDARY outcome

Timeframe: Baseline and every 2 weeks for 6 weeks

Population: Serum theophylline levels assessed at every follow-up were undetectable throughout the study period in all participants.

Plasma levels of theophylline were measured using fluorescence polarization technique. Minimum level will be 0 microgram/mL and maximum assay limit is 40 microgram/mL. Higher levels indicate increased systemic exposure to theophylline. Units on scale are microgram/mL.

Outcome measures

Outcome measures
Measure	Nasal Theophylline n=7 Participants 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 Theophylline: The study medication will be provided by Foundation Care.
Change From Baseline in Plasma Theophylline Level at 6 Weeks	0 microgram/mL Standard Deviation 0

Adverse Events

Nasal Theophylline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sagar Nigwekar

Mass General Hospital

Phone: 5857298636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place