Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Propionate plus Vitamin D3 | Active Comparator | Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season |
|
| Fluticasone Propionate plus Placebo | Placebo Comparator | Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | 4000 IU once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert M Naclerio, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Fluticasone Propionate Plus Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
2 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert M Naclerio, MD | University of Chicago | (773) 702-0080 | rnacleri@surgery.bsd.uchicago.edu |
Not provided
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo taken once daily |
|
| Fluticasone Propionate | Drug | 200 mcg daily, intranasal |
|
|
| Baseline and 2 weeks |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
|
| 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. | Median | Full Range | units on a scale | Baseline and 2 weeks |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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 | 0 | 18 | 0 | 18 |
Not provided
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |