Trial Outcomes & Findings for Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed) (NCT NCT01330017)

NCT ID: NCT01330017

Last Updated: 2015-03-11

Results Overview

The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 539 participants
• Primary outcome timeframe: Baseline, Day 7
• Results posted on: 2015-03-11

Participant Flow

Participant milestones

Measure	PE 10 mg PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
Overall Study STARTED	109	108	107	112	103
Overall Study COMPLETED	104	104	99	100	100
Overall Study NOT COMPLETED	5	4	8	12	3

Reasons for withdrawal

Measure	PE 10 mg PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
Overall Study Adverse Event	0	1	1	4	0
Overall Study Withdrawal by Subject	0	0	1	0	1
Overall Study Lost to Follow-up	0	0	1	0	0
Overall Study Protocol Violation	0	0	0	1	0
Overall Study Unknown Reason	5	3	5	7	2

Baseline Characteristics

Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

Baseline characteristics by cohort

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=103 Participants Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.	Total n=539 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 11.25 • n=5 Participants	36.8 years STANDARD_DEVIATION 11.08 • n=7 Participants	38.9 years STANDARD_DEVIATION 12.65 • n=5 Participants	39.6 years STANDARD_DEVIATION 13.10 • n=4 Participants	38.9 years STANDARD_DEVIATION 11.96 • n=21 Participants	38.7 years STANDARD_DEVIATION 12.04 • n=8 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	63 Participants n=7 Participants	73 Participants n=5 Participants	52 Participants n=4 Participants	61 Participants n=21 Participants	325 Participants n=8 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	45 Participants n=7 Participants	34 Participants n=5 Participants	60 Participants n=4 Participants	42 Participants n=21 Participants	214 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7

Population: The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication.

The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.

Outcome measures

Measure	PE 10 mg n=104 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=106 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=102 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=104 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=101 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score	-0.460 Units on a Scale Standard Deviation 0.5374	-0.499 Units on a Scale Standard Deviation 0.5042	-0.508 Units on a Scale Standard Deviation 0.5618	-0.461 Units on a Scale Standard Deviation 0.5308	-0.428 Units on a Scale Standard Deviation 0.5530

SECONDARY outcome

Timeframe: Baseline and Days 2, 3, 4, 5, 6, and 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.

Outcome measures

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=103 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Baseline (n = 109, 108, 106, 111, 102)	2.417 Units on a Scale Standard Deviation 0.4327	2.517 Units on a Scale Standard Deviation 0.3995	2.481 Units on a Scale Standard Deviation 0.4148	2.492 Units on a Scale Standard Deviation 0.3887	2.514 Units on a Scale Standard Deviation 0.4208
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 3 (n = 104, 104, 102, 103, 101)	-0.359 Units on a Scale Standard Deviation 0.7750	-0.362 Units on a Scale Standard Deviation 0.6883	-0.324 Units on a Scale Standard Deviation 0.7109	-0.369 Units on a Scale Standard Deviation 0.6679	-0.362 Units on a Scale Standard Deviation 0.6834
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 7 (n = 104, 103, 100, 99, 100)	-0.541 Units on a Scale Standard Deviation 0.8543	-0.472 Units on a Scale Standard Deviation 0.8186	-0.594 Units on a Scale Standard Deviation 0.8256	-0.539 Units on a Scale Standard Deviation 0.7858	-0.438 Units on a Scale Standard Deviation 0.8296
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 2 (n = 104, 106, 102, 104, 101)	-0.243 Units on a Scale Standard Deviation 0.6034	-0.200 Units on a Scale Standard Deviation 0.5940	-0.216 Units on a Scale Standard Deviation 0.6416	-0.308 Units on a Scale Standard Deviation 0.6630	-0.283 Units on a Scale Standard Deviation 0.6439
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 4 (n = 104, 104, 101, 102, 101)	-0.503 Units on a Scale Standard Deviation 0.7604	-0.439 Units on a Scale Standard Deviation 0.7179	-0.485 Units on a Scale Standard Deviation 0.7318	-0.510 Units on a Scale Standard Deviation 0.7924	-0.422 Units on a Scale Standard Deviation 0.7402
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 5 (n = 104, 104, 101, 100, 100)	-0.426 Units on a Scale Standard Deviation 0.7881	-0.458 Units on a Scale Standard Deviation 0.7118	-0.465 Units on a Scale Standard Deviation 0.7365	-0.474 Units on a Scale Standard Deviation 0.7762	-0.392 Units on a Scale Standard Deviation 0.7236
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 6 (n = 104, 104, 100, 100, 100)	-0.474 Units on a Scale Standard Deviation 0.7751	-0.612 Units on a Scale Standard Deviation 0.8283	-0.584 Units on a Scale Standard Deviation 0.7866	-0.474 Units on a Scale Standard Deviation 0.7525	-0.428 Units on a Scale Standard Deviation 0.7331

SECONDARY outcome

Timeframe: Baseline and Days 1, 2, 3, 4, 5, 6, and 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.

Outcome measures

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=103 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Baseline (n = 109, 108, 106, 111, 102)	2.376 Units on a Scale Standard Deviation 0.4521	2.361 Units on a Scale Standard Deviation 0.4577	2.363 Units on a Scale Standard Deviation 0.4514	2.362 Units on a Scale Standard Deviation 0.4476	2.380 Units on a Scale Standard Deviation 0.4846
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 1 (n = 102, 106, 101, 102, 101)	-0.321 Units on a Scale Standard Deviation 0.6107	-0.285 Units on a Scale Standard Deviation 0.5961	-0.359 Units on a Scale Standard Deviation 0.7701	-0.321 Units on a Scale Standard Deviation 0.6852	-0.287 Units on a Scale Standard Deviation 0.7003
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 7 (n = 104, 102, 100, 98, 100)	-0.613 Units on a Scale Standard Deviation 0.7920	-0.650 Units on a Scale Standard Deviation 0.7766	-0.588 Units on a Scale Standard Deviation 0.9323	-0.564 Units on a Scale Standard Deviation 0.7752	-0.520 Units on a Scale Standard Deviation 0.8781
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 4 (n = 104, 104, 101, 99, 100)	-0.536 Units on a Scale Standard Deviation 0.7524	-0.474 Units on a Scale Standard Deviation 0.7479	-0.597 Units on a Scale Standard Deviation 0.8653	-0.533 Units on a Scale Standard Deviation 0.8227	-0.450 Units on a Scale Standard Deviation 0.8142
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 5 (n = 104, 102, 97, 99, 99)	-0.526 Units on a Scale Standard Deviation 0.7398	-0.610 Units on a Scale Standard Deviation 0.7863	-0.564 Units on a Scale Standard Deviation 0.9052	-0.475 Units on a Scale Standard Deviation 0.7739	-0.485 Units on a Scale Standard Deviation 0.8870
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 6 (n = 104, 103, 100, 100, 100)	-0.613 Units on a Scale Standard Deviation 0.8539	-0.750 Units on a Scale Standard Deviation 0.8105	-0.648 Units on a Scale Standard Deviation 0.8624	-0.597 Units on a Scale Standard Deviation 0.8704	-0.470 Units on a Scale Standard Deviation 0.8515
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 2 (n = 102, 103, 102, 103, 101)	-0.360 Units on a Scale Standard Deviation 0.7240	-0.410 Units on a Scale Standard Deviation 0.6650	-0.483 Units on a Scale Standard Deviation 0.8177	-0.466 Units on a Scale Standard Deviation 0.7646	-0.386 Units on a Scale Standard Deviation 0.7988
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Day 3 (n = 104, 104, 101, 101, 101)	-0.546 Units on a Scale Standard Deviation 0.7289	-0.512 Units on a Scale Standard Deviation 0.7049	-0.527 Units on a Scale Standard Deviation 0.8440	-0.480 Units on a Scale Standard Deviation 0.7346	-0.505 Units on a Scale Standard Deviation 0.7818

SECONDARY outcome

Timeframe: Baseline and Day 2, 3, 4, 5, 6, and 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

Instantaneous assessment of nasal symptoms was performed once daily before the

morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.

Outcome measures

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=102 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Baseline (n = 107, 106, 104, 106, 101)	2.271 Units on a Scale Standard Deviation 0.6669	2.311 Units on a Scale Standard Deviation 0.6527	2.298 Units on a Scale Standard Deviation 0.6809	2.311 Units on a Scale Standard Deviation 0.6228	2.406 Units on a Scale Standard Deviation 0.6030
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Day 2 (n = 104, 105, 102, 103, 101)	-0.147 Units on a Scale Standard Deviation 0.6807	0.010 Units on a Scale Standard Deviation 0.7568	-0.060 Units on a Scale Standard Deviation 0.7361	-0.010 Units on a Scale Standard Deviation 0.6308	-0.180 Units on a Scale Standard Deviation 0.7572
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Day 4 (n = 104, 103,101,101, 101)	-0.324 Units on a Scale Standard Deviation 0.8462	-0.255 Units on a Scale Standard Deviation 0.8288	-0.253 Units on a Scale Standard Deviation 0.9186	-0.351 Units on a Scale Standard Deviation 0.8421	-0.280 Units on a Scale Standard Deviation 0.8297
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Day 5 (n = 104, 103, 101, 99, 101)	-0.304 Units on a Scale Standard Deviation 0.7550	-0.314 Units on a Scale Standard Deviation 0.8672	-0.283 Units on a Scale Standard Deviation 0.8456	-0.232 Units on a Scale Standard Deviation 0.8927	-0.240 Units on a Scale Standard Deviation 0.6980
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Day 3 (n = 104, 103, 102, 102, 101)	-0.265 Units on a Scale Standard Deviation 0.9002	-0.206 Units on a Scale Standard Deviation 0.7491	-0.130 Units on a Scale Standard Deviation 0.8246	-0.112 Units on a Scale Standard Deviation 0.8234	-0.130 Units on a Scale Standard Deviation 0.7740
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Day 6 (n = 104, 104, 100, 99, 100)	-0.353 Units on a Scale Standard Deviation 0.8402	-0.422 Units on a Scale Standard Deviation 0.9589	-0.337 Units on a Scale Standard Deviation 0.8961	-0.379 Units on a Scale Standard Deviation 0.8013	-0.260 Units on a Scale Standard Deviation 0.7333
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Day 7 (n = 104, 102, 100, 98, 100)	-0.382 Units on a Scale Standard Deviation 0.8330	-0.376 Units on a Scale Standard Deviation 0.9258	-0.408 Units on a Scale Standard Deviation 0.9176	-0.404 Units on a Scale Standard Deviation 0.8591	-0.380 Units on a Scale Standard Deviation 0.7625

SECONDARY outcome

Timeframe: Baseline and Days 1, 2, 3, 4, 5, 6, and 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.

Outcome measures

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=103 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 2 (n = 104, 106, 102, 104, 101)	-0.297 Units on a Scale Standard Deviation 0.5786	-0.320 Units on a Scale Standard Deviation 0.5181	-0.367 Units on a Scale Standard Deviation 0.5734	-0.392 Units on a Scale Standard Deviation 0.5406	-0.345 Units on a Scale Standard Deviation 0.6239
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 4 (n = 104, 104, 101, 102, 101)	-0.519 Units on a Scale Standard Deviation 0.6455	-0.468 Units on a Scale Standard Deviation 0.6256	-0.559 Units on a Scale Standard Deviation 0.6994	-0.520 Units on a Scale Standard Deviation 0.7017	-0.449 Units on a Scale Standard Deviation 0.6852
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 7 (n = 104, 103, 100, 99, 100)	-0.576 Units on a Scale Standard Deviation 0.7385	-0.573 Units on a Scale Standard Deviation 0.6821	-0.610 Units on a Scale Standard Deviation 0.7658	-0.556 Units on a Scale Standard Deviation 0.6695	-0.490 Units on a Scale Standard Deviation 0.7770
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 6 (n = 104, 104, 100, 100, 100)	-0.543 Units on a Scale Standard Deviation 0.7267	-0.689 Units on a Scale Standard Deviation 0.7241	-0.635 Units on a Scale Standard Deviation 0.6890	-0.544 Units on a Scale Standard Deviation 0.7232	-0.460 Units on a Scale Standard Deviation 0.6943
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 3 (n = 104, 104, 102, 103, 101)	-0.451 Units on a Scale Standard Deviation 0.6566	-0.449 Units on a Scale Standard Deviation 0.5989	-0.441 Units on a Scale Standard Deviation 0.6548	-0.425 Units on a Scale Standard Deviation 0.5806	-0.444 Units on a Scale Standard Deviation 0.6383
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 5 (n = 104, 104, 101, 100, 101)	-0.475 Units on a Scale Standard Deviation 0.6831	-0.550 Units on a Scale Standard Deviation 0.6478	-0.529 Units on a Scale Standard Deviation 0.7278	-0.484 Units on a Scale Standard Deviation 0.6992	-0.444 Units on a Scale Standard Deviation 0.6859
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Baseline (n = 109. 108, 106, 111, 102)	2.394 Units on a Scale Standard Deviation 0.3869	2.452 Units on a Scale Standard Deviation 0.3593	2.440 Units on a Scale Standard Deviation 0.3684	2.437 Units on a Scale Standard Deviation 0.3722	2.457 Units on a Scale Standard Deviation 0.4014
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Day 1 (n = 102, 106, 101, 102, 101)	-0.353 Units on a Scale Standard Deviation 0.5821	-0.367 Units on a Scale Standard Deviation 0.6130	-0.431 Units on a Scale Standard Deviation 0.7168	-0.389 Units on a Scale Standard Deviation 0.6408	-0.364 Units on a Scale Standard Deviation 0.6125

SECONDARY outcome

Timeframe: Baseline and Days 1, 2, 3, 4, 5, 6, and 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

Instantaneous assessment of nasal symptoms was performed once daily before the

morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.

Outcome measures

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=102 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Day 2 (n = 102, 104, 100, 99, 100)	-0.147 Units on a Scale Standard Deviation 0.6807	0.010 Units on a Scale Standard Deviation 0.7568	-0.060 Units on a Scale Standard Deviation 0.7361	-0.010 Units on a Scale Standard Deviation 0.6308	-0.180 Units on a Scale Standard Deviation 0.7572
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Day 5 (n = 102, 102, 99, 95, 100)	-0.304 Units on a Scale Standard Deviation 0.7550	-0.314 Units on a Scale Standard Deviation 0.8672	-0.283 Units on a Scale Standard Deviation 0.8456	-0.232 Units on a Scale Standard Deviation 0.8927	-0.240 Units on a Scale Standard Deviation 0.6980
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Day 3 (n = 102, 102, 100, 98, 100)	-0.265 Units on a Scale Standard Deviation 0.9002	-0.206 Units on a Scale Standard Deviation 0.7491	-0.130 Units on a Scale Standard Deviation 0.8246	-0.112 Units on a Scale Standard Deviation 0.8234	-0.130 Units on a Scale Standard Deviation 0.7740
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Baseline (n = 107, 106, 104, 106, 101)	2.271 Units on a Scale Standard Deviation 0.6669	2.311 Units on a Scale Standard Deviation 0.6527	2.298 Units on a Scale Standard Deviation 0.6809	2.311 Units on a Scale Standard Deviation 0.6228	2.406 Units on a Scale Standard Deviation 0.6030
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Day 4 (n = 102, 102, 99, 97, 100)	-0.324 Units on a Scale Standard Deviation 0.8462	-0.255 Units on a Scale Standard Deviation 0.8288	-0.253 Units on a Scale Standard Deviation 0.9186	-0.351 Units on a Scale Standard Deviation 0.8421	-0.280 Units on a Scale Standard Deviation 0.8297
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Day 6 (n =102, 102, 98, 95, 100)	-0.353 Units on a Scale Standard Deviation 0.8402	-0.422 Units on a Scale Standard Deviation 0.9589	-0.337 Units on a Scale Standard Deviation 0.8961	-0.379 Units on a Scale Standard Deviation 0.8013	-0.260 Units on a Scale Standard Deviation 0.7333
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Day 7 (n = 102, 101, 98, 94, 100)	-0.382 Units on a Scale Standard Deviation 0.8330	-0.376 Units on a Scale Standard Deviation 0.9258	-0.408 Units on a Scale Standard Deviation 0.9176	-0.404 Units on a Scale Standard Deviation 0.8591	-0.380 Units on a Scale Standard Deviation 0.7625

SECONDARY outcome

Timeframe: Baseline up to Day 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.

Outcome measures

Measure	PE 10 mg n=109 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Time to Maximal Effect	5.5 Days	5.5 Days	5.5 Days	5.5 Days	—

SECONDARY outcome

Timeframe: Baseline, Day 7

Population: The ITT population included all randomized participants who received at least 1 dose of study medication.

The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.

Outcome measures

Measure	PE 10 mg n=102 Participants PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=101 Participants PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=98 Participants PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=94 Participants PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=100 Participants Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7	-0.382 Units on a Scale Standard Deviation 0.8330	-0.376 Units on a Scale Standard Deviation 0.9258	-0.408 Units on a Scale Standard Deviation 0.9176	-0.404 Units on a Scale Standard Deviation 0.8591	-0.380 Units on a Scale Standard Deviation 0.7625

Adverse Events

PE 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

PE 20 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PE 30 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PE 40 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PE 10 mg n=109 participants at risk PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 participants at risk PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 participants at risk PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 participants at risk PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=103 participants at risk Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
General disorders Chest Pain	0.00% 0/109	0.00% 0/108	0.00% 0/107	0.89% 1/112 • Number of events 1	0.00% 0/103
Musculoskeletal and connective tissue disorders Pain in Jaw	0.00% 0/109	0.00% 0/108	0.00% 0/107	0.89% 1/112 • Number of events 1	0.00% 0/103

Other adverse events

Measure	PE 10 mg n=109 participants at risk PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 20 mg n=108 participants at risk PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 30 mg n=107 participants at risk PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.	PE 40 mg n=112 participants at risk PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.	Placebo n=103 participants at risk Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
Nervous system disorders Headache	5.5% 6/109 • Number of events 6	3.7% 4/108 • Number of events 4	2.8% 3/107 • Number of events 3	2.7% 3/112 • Number of events 3	0.00% 0/103

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission or publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER