Seasonal Allergic Rhinitis
Conditions
Brief summary
People with allergies frequently complain of a loss or reduction in the sense of smell. In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.
Interventions
DRUGMometasone
2 puffs in each nostril once daily of nasal spray
DRUGPlacebo
2 puffs in each nostril once daily of nasal spray
Sponsors
Schering-Plough
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between 18 and 59 years of age. 2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction. 3. Positive skin or RAST test to allergen. 4. Symptoms of olfactory dysfunction. 5. No significant history of chronic sinusitis.
Exclusion criteria
1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding. 2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 3. Use of any other investigational agent in the last 30 days. 4. Absence of olfactory or nasal symptoms. 5. Use of medications that may affect olfaction. 6. Medical conditions that may affect olfaction. 7. Smoking. 8. URI at the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological Findings | 2 weeks | Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score at 2 Weeks | baseline and 2 weeks | A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27. |
| Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks | baseline and 2 weeks | An increase between visits indicates improved nasal airflow. |
| Change From Baseline in Percentage of Eosinophils at 2 Weeks | baseline and 2 weeks | A decrease between visits signifies a reduction in inflammation. Calculated from cytology specimens obtained by lavage. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled during relevant allergy seasons in Chicago, IL, from 2006 to 2008.
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Active intranasal steroid therapy daily for 2 weeks | 8 |
| Placebo 2 puffs of placebo spray once daily | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Mometasone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 38 years | 39 years |
| Allergen sensitivity Grass | 3 participants | 3 participants | 6 participants |
| Allergen sensitivity Ragweed | 5 participants | 6 participants | 11 participants |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
Histological Findings
Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mometasone | Histological Findings | 0.167 eosinophils per HPF |
| Placebo | Histological Findings | 2.67 eosinophils per HPF |
p-value: <0.02Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks
An increase between visits indicates improved nasal airflow.
Time frame: baseline and 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mometasone | Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks | 19.2 liters per minute |
| Placebo | Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks | -37.5 liters per minute |
p-value: <0.002t-test, 2 sided
Secondary
Change From Baseline in Percentage of Eosinophils at 2 Weeks
A decrease between visits signifies a reduction in inflammation. Calculated from cytology specimens obtained by lavage.
Time frame: baseline and 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mometasone | Change From Baseline in Percentage of Eosinophils at 2 Weeks | -1.35 percentage of eosinophils |
| Placebo | Change From Baseline in Percentage of Eosinophils at 2 Weeks | -0.1 percentage of eosinophils |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Total Nasal Symptom Score at 2 Weeks
A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.
Time frame: baseline and 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mometasone | Change From Baseline in Total Nasal Symptom Score at 2 Weeks | -12 units on a scale |
| Placebo | Change From Baseline in Total Nasal Symptom Score at 2 Weeks | -5 units on a scale |
p-value: <0.023Wilcoxon (Mann-Whitney)