Trial Outcomes & Findings for A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge (NCT NCT00562120)

Last Updated: 2014-04-16

Results Overview

Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Results posted on

2014-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.	PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.	Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.	Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
First Intervention Period STARTED	6	5	5	5
First Intervention Period Treated	5	5	5	5
First Intervention Period COMPLETED	4	5	5	5
First Intervention Period NOT COMPLETED	2	0	0	0
Washout Period 1 (At Least 14 Days) STARTED	4	5	5	5
Washout Period 1 (At Least 14 Days) COMPLETED	4	5	5	5
Washout Period 1 (At Least 14 Days) NOT COMPLETED	0	0	0	0
Second Intervention Period STARTED	4	5	5	5
Second Intervention Period COMPLETED	4	5	5	5
Second Intervention Period NOT COMPLETED	0	0	0	0
Washout Period 2 (At Least 14 Days) STARTED	4	5	5	5
Washout Period 2 (At Least 14 Days) COMPLETED	4	5	5	5
Washout Period 2 (At Least 14 Days) NOT COMPLETED	0	0	0	0
Third Intervention Period STARTED	4	5	5	5
Third Intervention Period COMPLETED	4	5	5	5
Third Intervention Period NOT COMPLETED	0	0	0	0
Washout Period 3 (At Least 14 Days) STARTED	4	5	5	5
Washout Period 3 (At Least 14 Days) COMPLETED	4	5	5	5
Washout Period 3 (At Least 14 Days) NOT COMPLETED	0	0	0	0
Fourth Intervention Period STARTED	4	5	5	5
Fourth Intervention Period COMPLETED	4	5	5	5
Fourth Intervention Period NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.	PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.	Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.	Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
First Intervention Period Adverse Event	1	0	0	0
First Intervention Period Randomized but not Treated	1	0	0	0

Baseline Characteristics

A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=20 Participants All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
Age, Customized 18 to 44 years	15 participants n=5 Participants
Age, Customized 45 to 64 years	5 participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry	0.760 ratio Standard Deviation 0.1504	0.742 ratio Standard Deviation 0.2552	0.717 ratio Standard Deviation 0.1935	0.795 ratio Standard Deviation 0.3044

PRIMARY outcome

Timeframe: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Nasal Volume Proportion Measured Using Acoustic Rhinometry	0.800 ratio Standard Deviation 0.1825	0.796 ratio Standard Deviation 0.2641	0.744 ratio Standard Deviation 0.1594	0.856 ratio Standard Deviation 0.3859

SECONDARY outcome

Timeframe: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest 'post-allergen challenge' Amin measurement of the 3 measures.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry	0.155 square centimeter (cm^2) Standard Deviation 0.0876	0.157 square centimeter (cm^2) Standard Deviation 0.1159	0.204 square centimeter (cm^2) Standard Deviation 0.0951	0.190 square centimeter (cm^2) Standard Deviation 0.1510

SECONDARY outcome

Timeframe: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest 'post-allergen challenge' nasal volume measurement among the 3 measures.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry	3.132 cubic centimeter (cm^3) Standard Deviation 2.4120	3.244 cubic centimeter (cm^3) Standard Deviation 2.3676	4.443 cubic centimeter (cm^3) Standard Deviation 2.9502	3.275 cubic centimeter (cm^3) Standard Deviation 2.7001

SECONDARY outcome

Timeframe: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for 'post-diluent, pre-allergen challenge' measure and 'post-challenge' measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Nasal congestion: Pre-allergen challenge	0.2 units on a scale Standard Deviation 0.36	0.4 units on a scale Standard Deviation 0.42	0.4 units on a scale Standard Deviation 0.57	0.4 units on a scale Standard Deviation 0.59
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Nasal congestion: Post-allergen challenge	1.5 units on a scale Standard Deviation 1.20	1.8 units on a scale Standard Deviation 1.30	1.9 units on a scale Standard Deviation 1.42	2.2 units on a scale Standard Deviation 1.48
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Nasal congestion: Post-oxymetazoline	0.8 units on a scale Standard Deviation 1.16	0.8 units on a scale Standard Deviation 1.21	0.9 units on a scale Standard Deviation 0.85	0.9 units on a scale Standard Deviation 1.20
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Nasal Itching: Pre-allergen challenge	0.0 units on a scale Standard Deviation 0.07	0.1 units on a scale Standard Deviation 0.23	0.0 units on a scale Standard Deviation 0.08	0.1 units on a scale Standard Deviation 0.31
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Nasal Itching: Post-allergen challenge	0.4 units on a scale Standard Deviation 0.71	0.8 units on a scale Standard Deviation 1.10	0.9 units on a scale Standard Deviation 1.12	1.4 units on a scale Standard Deviation 1.43
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Rhinorrhea: Pre-allergen challenge	0.1 units on a scale Standard Deviation 0.23	0.1 units on a scale Standard Deviation 0.17	0.2 units on a scale Standard Deviation 0.39	0.1 units on a scale Standard Deviation 0.33
Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea Rhinorrhea: Post-allergen challenge	0.6 units on a scale Standard Deviation 1.01	1.1 units on a scale Standard Deviation 1.48	1.3 units on a scale Standard Deviation 1.30	1.9 units on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where 'post-diluent, pre-allergen challenge' included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and 'post-allergen challenge' included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 Participants Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Nasal Symptom Scores: Sneezing Sneezing: Pre-allergen challenge	0.0 sneezes Standard Deviation 0.07	0.1 sneezes Standard Deviation 0.23	0.1 sneezes Standard Deviation 0.61	0.1 sneezes Standard Deviation 0.17
Nasal Symptom Scores: Sneezing Sneezing: Post-allergen challenge	0.7 sneezes Standard Deviation 1.54	0.6 sneezes Standard Deviation 0.92	1.2 sneezes Standard Deviation 1.94	3.6 sneezes Standard Deviation 3.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hr 30 min post dose on Day 1 of each intervention period

Population: Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.

Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.

Outcome measures

Outcome measures
Measure	PF-03654746 10 mg n=20 Participants PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 Participants PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Serum PF-03654746 Concentration	34.16 nanogram per milliliter (ng/mL) Standard Deviation 17.85	2.78 nanogram per milliliter (ng/mL) Standard Deviation 1.55	—	—

Adverse Events

PF-03654746 10 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

PF-03654746 1 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Allegra-D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PF-03654746 10 mg n=20 participants at risk PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	PF-03654746 1 mg n=19 participants at risk PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Allegra-D n=19 participants at risk Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.	Placebo n=19 participants at risk Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
General disorders Feeling jittery	5.0% 1/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Infections and infestations Bronchitis	0.00% 0/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	5.3% 1/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Infections and infestations Gastroenteritis	5.0% 1/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Infections and infestations Sinusitis	0.00% 0/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	5.3% 1/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Infections and infestations Urinary tract infection	5.0% 1/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	5.3% 1/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	5.3% 1/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Metabolism and nutrition disorders Anorexia	5.0% 1/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Psychiatric disorders Disorientation	5.0% 1/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Psychiatric disorders Hallucination	5.0% 1/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Psychiatric disorders Insomnia	10.0% 2/20 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	5.3% 1/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.	0.00% 0/19 All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER