Trial Outcomes & Findings for Vitamin D Plus Fluticasone Propionate (NCT NCT01103934)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Baseline and 2 weeks

Results posted on

2014-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	17	18
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Plus Fluticasone Propionate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Propionate Plus Vitamin D3 n=17 Participants 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	Fluticasone Propionate Plus Placebo n=18 Participants 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	Total n=35 Participants Total of all reporting groups
Age, Continuous	27.3 years STANDARD_DEVIATION 6.1 • n=5 Participants	29.5 years STANDARD_DEVIATION 9.3 • n=7 Participants	28.4 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Plus Vitamin D3 n=17 Participants 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	Fluticasone Propionate Plus Placebo n=18 Participants 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
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period	-11.3 units on a scale Interval -18.9 to 8.8	-7.6 units on a scale Interval -18.7 to 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Plus Vitamin D3 n=17 Participants 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	Fluticasone Propionate Plus Placebo n=18 Participants 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
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period	-6.9 units on a scale Interval -10.2 to 5.2	-3.7 units on a scale Interval -10.6 to -0.2

Adverse Events

Fluticasone Propionate Plus Vitamin D3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluticasone Propionate Plus Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert M Naclerio, MD

University of Chicago

Phone: (773) 702-0080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place