Trial Outcomes & Findings for Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis (NCT NCT02402465)
NCT ID: NCT02402465
Last Updated: 2024-10-17
Results Overview
Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (albumin amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.
Results posted on
2024-10-17
Participant Flow
cross-over study
Participant milestones
| Measure |
Dymista/Placebo/Flonase
Randomized order of Dymista, then Placebo, then Flonase
|
Dymista/Flonase/Placebo
Randomized order of Dymista, then Flonase, then Placebo
|
Placebo/Dymista/Flonase
Randomized order of Placebo, then Dymista, then Flonase
|
Placebo/Flonase/Dymista
Randomized order of Placebo, then Flonase, then Dymista
|
Flonase/Dymista/Placebo
Randomized order of Flonase, then Dymista, then Placebo
|
Flonase/Placebo/Dymista
Randomized order of Flonase, then Placebo, then Dymista
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
2
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
4
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dymista/Placebo/Flonase
Randomized order of Dymista, then Placebo, then Flonase
|
Dymista/Flonase/Placebo
Randomized order of Dymista, then Flonase, then Placebo
|
Placebo/Dymista/Flonase
Randomized order of Placebo, then Dymista, then Flonase
|
Placebo/Flonase/Dymista
Randomized order of Placebo, then Flonase, then Dymista
|
Flonase/Dymista/Placebo
Randomized order of Flonase, then Dymista, then Placebo
|
Flonase/Placebo/Dymista
Randomized order of Flonase, then Placebo, then Dymista
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Dymista/Placebo/Flonase
n=4 Participants
Dymista:
Fluticasone/Azelastine nasal spray
Flonase: Fluticasone nasal spray
Placebo: nasal spray without active ingredient
|
Dymista/Flonase/Placebo
n=3 Participants
Dymista:
Fluticasone/Azelastine nasal spray
Flonase: Fluticasone nasal spray
Placebo: nasal spray without active ingredient
|
Placebo/Dymista/Flonase
n=4 Participants
Dymista:
Fluticasone/Azelastine nasal spray
Flonase: Fluticasone nasal spray
Placebo: nasal spray without active ingredient
|
Placebo/Flonase/Dymista
n=4 Participants
Dymista:
Fluticasone/Azelastine nasal spray
Flonase: Fluticasone nasal spray
Placebo: nasal spray without active ingredient
|
Flonase/Dymista/Placebo
n=1 Participants
Dymista:
Fluticasone/Azelastine nasal spray
Flonase: Fluticasone nasal spray
Placebo: nasal spray without active ingredient
|
Flonase/Placebo/Dymista
n=3 Participants
Dymista:
Fluticasone/Azelastine nasal spray
Flonase: Fluticasone nasal spray
Placebo: nasal spray without active ingredient
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
34.5 years
n=5 Participants
|
29 years
n=7 Participants
|
29 years
n=5 Participants
|
27 years
n=4 Participants
|
42 years
n=21 Participants
|
36 years
n=8 Participants
|
34 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (albumin amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=19 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=19 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Change From Baseline Response in Albumin Levels in Nasal Lavage Following Each Challenge
day 1
|
-33.61 ng/mL
Standard Error 53.03
|
-82.2 ng/mL
Standard Error 54.22
|
-185.85 ng/mL
Standard Error 158.04
|
|
Change From Baseline Response in Albumin Levels in Nasal Lavage Following Each Challenge
day 2
|
-41.87 ng/mL
Standard Error 59.22
|
-29.70 ng/mL
Standard Error 72.14
|
-81.6 ng/mL
Standard Error 32.36
|
|
Change From Baseline Response in Albumin Levels in Nasal Lavage Following Each Challenge
day 3
|
-106.68 ng/mL
Standard Error 46.08
|
-78.73 ng/mL
Standard Error 58.44
|
-69.50 ng/mL
Standard Error 35.49
|
SECONDARY outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Our procedure used a diluent (sham) challenge followed by 2 allergen challenges. The final value is (the number of sneezes after 1st allergen exposure - number after sham) + (number of sneezes after 2nd exposure - sham amount).
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=19 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=19 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Sneezes After Allergen Challenge
day 1
|
6.2 Sneezes
Standard Error 2.2
|
6.8 Sneezes
Standard Error 1.6
|
1.1 Sneezes
Standard Error 0.5
|
|
Sneezes After Allergen Challenge
Day 2
|
9.3 Sneezes
Standard Error 2.6
|
7.6 Sneezes
Standard Error 2.2
|
2.0 Sneezes
Standard Error 0.9
|
|
Sneezes After Allergen Challenge
day 3
|
9.0 Sneezes
Standard Error 2.5
|
7.1 Sneezes
Standard Error 2.0
|
2.1 Sneezes
Standard Error 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Total nasal symptom Score = Sum of itchy, runny, sneezing, and congestion scores, each on scale 0-3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms). Thus, maximum=12, minimum=0, and higher score represents worse outcome. Measured in the 10 minute period after allergen challenge and normalized against symptoms experienced after sham challenge.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=19 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=19 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Total Nasal Symptom Score
day 1
|
6.26 score on a scale
Standard Error 0.85
|
7.06 score on a scale
Standard Error 1.08
|
3.58 score on a scale
Standard Error 0.81
|
|
Total Nasal Symptom Score
day 2
|
6.63 score on a scale
Standard Error 1.13
|
6.44 score on a scale
Standard Error 0.91
|
4.32 score on a scale
Standard Error 0.86
|
|
Total Nasal Symptom Score
day 3
|
5.68 score on a scale
Standard Error 1.07
|
5.67 score on a scale
Standard Error 0.89
|
4.22 score on a scale
Standard Error 0.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Population: There was one missing sample
Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (lactoferrin amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=18 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=18 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Change From Baseline Response in Lactoferrin Levels in Nasal Lavage Following Each Challenge
|
131368 ng/mL
Standard Error 67483
|
137539 ng/mL
Standard Error 40363
|
31400 ng/mL
Standard Error 44982
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Population: due technical difficulty in the staining, no data is available.
Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (number of eosinophils in lavage after 1st allergen exposure - number after sham) + (number in lavage after 2nd exposure - sham number).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Population: there were three missing samples
Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (histamine amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=16 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=16 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Histamine
|
-0.97 ng/mL
Standard Error 1.2
|
10.3 ng/mL
Standard Error 7.6
|
12.3 ng/mL
Standard Error 9.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Population: Data was missing for 3 subjects
Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (tryptase amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=16 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=16 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Tryptase
|
-0.08 ng/ml
Standard Error 0.28
|
-0.19 ng/ml
Standard Error 0.39
|
0.12 ng/ml
Standard Error 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 rounds of 1 Nasal challenge every 3 days followed by 2 week washout periods in between. Total participation of 9 weeks.Our procedure used a diluent (sham) challenge followed by 2 allergen challenges where lavages are collected 10 minutes after each of these challenges. The final value is (ECP amount in lavage after 1st allergen exposure - amount after sham) + (amount in lavage after 2nd exposure - sham amount).
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo nasal spray that is similar to Dymista in all respects except the active ingredient
Placebo: Patients will be treated by placebo
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Fluticasone Propionate
n=19 Participants
Fluticasone propionate nasal spray provided in a bottle similar to placebo and dymista
Fluticasone propionate: Patients will receive fluticasone nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
Dymista (Fluticasone/Azelastine)
n=19 Participants
Dymista is also provided as a nasal spray in bottles similar to the other two agents
Fluticasone/Azelastine nasal spray: Patients will receive Dymista nasal spray
Nasal Allergen Challenge: All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
|
|---|---|---|---|
|
Eosinophil Cationic Protein (ECP)
day 1
|
47.08 ng/mL
Standard Error 14.67
|
47.8 ng/mL
Standard Error 13.46
|
51.62 ng/mL
Standard Error 13.03
|
|
Eosinophil Cationic Protein (ECP)
day 2
|
44.5 ng/mL
Standard Error 13.18
|
36.13 ng/mL
Standard Error 11
|
46.32 ng/mL
Standard Error 14.65
|
|
Eosinophil Cationic Protein (ECP)
day 3
|
42.4 ng/mL
Standard Error 10.25
|
37.91 ng/mL
Standard Error 10.77
|
53.33 ng/mL
Standard Error 16.14
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluticasone Propionate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dymista (Fluticasone/Azelastine)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place