Seasonal Allergic Rhinitis
Conditions
Brief summary
We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.
Interventions
DRUGmometasone furoate nasal spray
2 puffs in each nostril once a day for 2 weeks
DRUGplacebo
2 puffs in each nostril once a day for 2 weeks
Sponsors
Schering-Plough
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between 18 and 60 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin or RAST test to grass, trees and/or ragweed antigen. 4. Symptomatic at time of entry into study.
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 pregnant or 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 nasal symptoms. 5. Smoking. 6. URI at the time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment | at week 2 | Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in RQLQ: Activity | Baseline and 2 weeks | The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life. |
| Changes in RQLQ: Sleep | Baseline and 2 weeks | The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life. |
| Changes in RQLQ: Non-Nasal/Eye | Baseline and 2 weeks | The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life. |
| Changes in RQLQ: Overall | Baseline and 2 weeks | The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores. |
| Changes in RQLQ: Nasal | Baseline and 2 weeks | The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life. |
| Changes in RQLQ: Emotional | Baseline and 2 weeks | The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life. |
| Changes in RQLQ: Eye | Baseline and 2 weeks | The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life. |
| Changes in RQLQ: Practical | Baseline and 2 weeks | The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate 2 weeks of treatment
mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks | 20 |
| Placebo 2 weeks of treatment
placebo : 2 puffs in each nostril once a day for 2 weeks | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Mometasone Furoate | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 9.36 | 35 years STANDARD_DEVIATION 12 | 33.8 years STANDARD_DEVIATION 10.98 |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Global Assessment
Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse
Time frame: at week 2
Population: There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Global Assessment | 1.7 units on a scale | Standard Deviation 1.1 |
| Placebo | Global Assessment | 1.4 units on a scale | Standard Deviation 1.2 |
p-value: 0.372t-test, 2 sided
Secondary
Changes in RQLQ: Activity
The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Activity | -1.73 units on a scale | Standard Deviation 1.64 |
| Placebo | Changes in RQLQ: Activity | -1.55 units on a scale | Standard Deviation 1.78 |
p-value: 0.737t-test, 2 sided
Secondary
Changes in RQLQ: Emotional
The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
Population: There were one patient in the Mometasone Furoate group with a missing value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Emotional | -1.05 units on a scale | Standard Deviation 1.57 |
| Placebo | Changes in RQLQ: Emotional | -0.94 units on a scale | Standard Deviation 1.24 |
p-value: 0.8t-test, 2 sided
Secondary
Changes in RQLQ: Eye
The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Eye | -1.36 units on a scale | Standard Deviation 1.41 |
| Placebo | Changes in RQLQ: Eye | -1.34 units on a scale | Standard Deviation 1.32 |
p-value: 0.968t-test, 2 sided
Secondary
Changes in RQLQ: Nasal
The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Nasal | -1.54 units on a scale | Standard Deviation 1.47 |
| Placebo | Changes in RQLQ: Nasal | -1.31 units on a scale | Standard Deviation 1.53 |
p-value: 0.638t-test, 2 sided
Secondary
Changes in RQLQ: Non-Nasal/Eye
The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Non-Nasal/Eye | -1.11 units on a scale | Standard Deviation 1.05 |
| Placebo | Changes in RQLQ: Non-Nasal/Eye | -1.26 units on a scale | Standard Deviation 1.22 |
p-value: 0.676t-test, 2 sided
Secondary
Changes in RQLQ: Overall
The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Overall | -1.35 units on a scale | Standard Deviation 1.09 |
| Placebo | Changes in RQLQ: Overall | -1.25 units on a scale | Standard Deviation 1.09 |
p-value: 0.775t-test, 2 sided
Secondary
Changes in RQLQ: Practical
The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Practical | -1.37 units on a scale | Standard Deviation 1.26 |
| Placebo | Changes in RQLQ: Practical | -1.48 units on a scale | Standard Deviation 1.54 |
p-value: 0.795t-test, 2 sided
Secondary
Changes in RQLQ: Sleep
The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate | Changes in RQLQ: Sleep | -1.42 units on a scale | Standard Deviation 1.18 |
| Placebo | Changes in RQLQ: Sleep | -0.85 units on a scale | Standard Deviation 1.05 |
p-value: 0.117t-test, 2 sided