Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.
Interventions
DRUGfluticasone furoate
2 puffs in each nostril once daily for 1 week
DRUGPlacebo
2 puffs in each nostril once daily for 1 week
Sponsors
GlaxoSmithKline
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between 18 and 45 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin test to grass and/or ragweed antigen. 4. Positive response to screening nasal challenge.
Exclusion criteria
1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Upper respiratory infection within 14 days of study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tryptase Level From Baseline to Post-antigen Challenge | After one week of treatment wtih veramyst or placebo | Tryptase levels (mcg/L) were measured from nasal lavages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Eye Symptom Scores After Antigen Challenge | After one week of treatment wtih veramyst or placebo | Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe |
Countries
United States
Participant flow
Recruitment details
24 subjects were screened for eligibility
Pre-assignment details
15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups
Participants by arm
| Arm | Count |
|---|---|
| Veramyst, Then Placbeo fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week | 8 |
| Placebo, Then Veramyst placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Placebo, Then Veramyst | Veramyst, Then Placbeo | Total |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 6 | 32 years STANDARD_DEVIATION 11 | 30 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Tryptase Level From Baseline to Post-antigen Challenge
Tryptase levels (mcg/L) were measured from nasal lavages
Time frame: After one week of treatment wtih veramyst or placebo
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Veramyst | Change in Tryptase Level From Baseline to Post-antigen Challenge | 0 mcg/L |
| Placebo | Change in Tryptase Level From Baseline to Post-antigen Challenge | 2.31 mcg/L |
p-value: 0.33Wilcoxon signed-rank test
Secondary
Total Eye Symptom Scores After Antigen Challenge
Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
Time frame: After one week of treatment wtih veramyst or placebo
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Veramyst | Total Eye Symptom Scores After Antigen Challenge | 3 units on a scale |
| Placebo | Total Eye Symptom Scores After Antigen Challenge | 3 units on a scale |
p-value: 0.14Wilcoxon signed-rank test