Trial Outcomes & Findings for Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial (NCT NCT00745849)

Last Updated: 2019-06-11

Results Overview

(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm

Recruitment status

COMPLETED

Study phase

Target enrollment

43 participants

Primary outcome timeframe

Last two weeks of each treatment arm

Results posted on

2019-06-11

Participant Flow

Patients were recruited from UT Southwestern outpatient clinics as well as through flyers and local advertising

43 patients were assigned for randomization after meeting inclusion criteria: age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English

Participant milestones

Participant milestones
Measure	Placebo First, Then Esomeprazole Placebo twice daily for 8 weeks, then two week washout, then Esomeprazole 40mg twice daily for 8 weeks	Esomeprazole First, Then Placebo Esomeprazole 40mg twice daily for 8 weeks, then two week washout, then Placebo twice daily for 8 weeks
First Intervention STARTED	21	22
First Intervention COMPLETED	20	20
First Intervention NOT COMPLETED	1	2
Washout Period STARTED	20	20
Washout Period COMPLETED	20	20
Washout Period NOT COMPLETED	0	0
Second Intervention STARTED	20	20
Second Intervention COMPLETED	18	19
Second Intervention NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo First, Then Esomeprazole Placebo twice daily for 8 weeks, then two week washout, then Esomeprazole 40mg twice daily for 8 weeks	Esomeprazole First, Then Placebo Esomeprazole 40mg twice daily for 8 weeks, then two week washout, then Placebo twice daily for 8 weeks
First Intervention Withdrawal by Subject	0	1
First Intervention Lost to Follow-up	1	1
Second Intervention Lost to Follow-up	2	1

Baseline Characteristics

Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=37 Participants 37 patients were included in Data Analysis. Study subjects were randomized to esomeprazole 40mg tablet twice daily or placebo for eight weeks each, with a two week washout crossover period in between treatment arms.
Age, Continuous	44.9 years n=99 Participants
Sex: Female, Male Female	26 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Baseline Reflux Score	4.8 units on a scale n=99 Participants
Number of Patients on Intranasal Corticosteroids	4 Participants n=99 Participants
Number of Patients on Oral Antihistamines	9 Participants n=99 Participants
Number of Patients on Oral Leukotriene Receptor Antagonists	5 Participants n=99 Participants
Number of Patients on Intranasal Antihistamines	1 Participants n=99 Participants
Number of Patients on Intranasal Anticholinergics	2 Participants n=99 Participants
Number of Patients on Oral Decongestants	4 Participants n=99 Participants
Number of Patients on Intranasal Decongestants	2 Participants n=99 Participants
Number of Patients on Nasal Saline Rinses	3 Participants n=99 Participants
Number of Patients on Oral Antacids (none in two weeks prior to enrollment)	7 Participants n=99 Participants
Nasal Symptom Score : Sneezing	2.8 units on a scale n=99 Participants
Nasal Symptom Score : Runny Nose	3.8 units on a scale n=99 Participants
Nasal Symptom Score : Congestion	4.4 units on a scale n=99 Participants
Nasal Symptom Score : Itchy Nose	2.9 units on a scale n=99 Participants
Nasal Symptom Score : Postnasal Drip	4.4 units on a scale n=99 Participants
Nasal Symptom Score : Total Nasal Symptoms	4.8 units on a scale n=99 Participants

PRIMARY outcome

Timeframe: Last two weeks of each treatment arm

Population: Each study participant was in both arms of the study since this was a crossover study

(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm

Outcome measures

Outcome measures
Measure	Esomeprazole Arm n=37 Participants esomeprazole: 40mg by mouth twice daily for 8 weeks	Placebo Arm n=37 Participants placebo twice daily for 8 weeks
Total Nasal Symptom Scores	3.0 score on a scale Interval 1.0 to 6.0	3.1 score on a scale Interval 1.0 to 6.0

Adverse Events

Events Occurring While Subject Was on Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Events Occurring While Subject Was on Esomeprazole

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

Ganesh Shanmugam, MD

University of Texas Southwestern

Phone: 9797036112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place