Vasomotor Rhinitis
Conditions
Keywords
non-allergic rhinitis, laryngopharyngeal reflux
Brief summary
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis
Interventions
DRUGesomeprazole
40mg by mouth twice daily
DRUGplacebo
Sponsors
AstraZeneca
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Exclusion criteria
* pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Scores | Last two weeks of each treatment arm | (1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from UT Southwestern outpatient clinics as well as through flyers and local advertising
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population 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. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Lost to Follow-up | 1 | 1 |
| First Intervention | Withdrawal by Subject | 0 | 1 |
| Second Intervention | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 44.9 years |
| Baseline Reflux Score | 4.8 units on a scale |
| Nasal Symptom Score : Congestion | 4.4 units on a scale |
| Nasal Symptom Score : Itchy Nose | 2.9 units on a scale |
| Nasal Symptom Score : Postnasal Drip | 4.4 units on a scale |
| Nasal Symptom Score : Runny Nose | 3.8 units on a scale |
| Nasal Symptom Score : Sneezing | 2.8 units on a scale |
| Nasal Symptom Score : Total Nasal Symptoms | 4.8 units on a scale |
| Number of Patients on Intranasal Anticholinergics | 2 Participants |
| Number of Patients on Intranasal Antihistamines | 1 Participants |
| Number of Patients on Intranasal Corticosteroids | 4 Participants |
| Number of Patients on Intranasal Decongestants | 2 Participants |
| Number of Patients on Nasal Saline Rinses | 3 Participants |
| Number of Patients on Oral Antacids (none in two weeks prior to enrollment) | 7 Participants |
| Number of Patients on Oral Antihistamines | 9 Participants |
| Number of Patients on Oral Decongestants | 4 Participants |
| Number of Patients on Oral Leukotriene Receptor Antagonists | 5 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Total Nasal Symptom Scores
(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm
Time frame: Last two weeks of each treatment arm
Population: Each study participant was in both arms of the study since this was a crossover study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Esomeprazole Arm | Total Nasal Symptom Scores | 3.0 score on a scale |
| Placebo Arm | Total Nasal Symptom Scores | 3.1 score on a scale |
p-value: 0.45t-test, 2 sided