Seasonal Allergic Rhinitis
Conditions
Brief summary
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
Interventions
DRUGVitamin D3
4000 IU once daily
DRUGPlacebo
Placebo taken once daily
DRUGFluticasone Propionate
200 mcg daily, intranasal
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between 18 and 45 years of age. 2. History of tree, grass and/or ragweed allergic rhinitis. 3. Positive skin test to tree, 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 From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period | Baseline and 2 weeks | Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period | Baseline and 2 weeks | Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Propionate Plus Vitamin D3 Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season
Vitamin D3: 4000 IU once daily
Fluticasone Propionate: 200 mcg daily, intranasal | 17 |
| Fluticasone Propionate Plus Placebo Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Placebo: Placebo taken once daily
Fluticasone Propionate: 200 mcg daily, intranasal | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | Fluticasone Propionate Plus Vitamin D3 | Fluticasone Propionate Plus Placebo | Total |
|---|---|---|---|
| Age, Continuous | 27.3 years STANDARD_DEVIATION 6.1 | 29.5 years STANDARD_DEVIATION 9.3 | 28.4 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment United States | 17 participants | 18 participants | 35 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fluticasone Propionate Plus Vitamin D3 | Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period | -11.3 units on a scale |
| Fluticasone Propionate Plus Placebo | Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period | -7.6 units on a scale |
p-value: 0.09Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fluticasone Propionate Plus Vitamin D3 | Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period | -6.9 units on a scale |
| Fluticasone Propionate Plus Placebo | Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period | -3.7 units on a scale |
p-value: 0.04Wilcoxon (Mann-Whitney)