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An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Allegra | Active Comparator |
| |
| Allegra-D | Active Comparator |
| |
| PF-03654746 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry | 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. | 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 |
| Nasal Volume Proportion Measured Using Acoustic Rhinometry | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum PF-03654746 Concentration | Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period. | 1 hr 30 min post dose on Day 1 of each intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
|
| |||||||||||||||||||||
| Washout Period 1 (At Least 14 Days) |
| ||||||||||||||||||||||
| Second Intervention Period |
| ||||||||||||||||||||||
| Washout Period 2 (At Least 14 Days) |
| ||||||||||||||||||||||
| Third Intervention Period |
| ||||||||||||||||||||||
| Washout Period 3 (At Least 14 Days) |
| ||||||||||||||||||||||
| Fourth Intervention Period |
|
Safety analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry | 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. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | ratio | 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 |
Not provided
All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-03654746 10 mg | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling jittery | General disorders | MedDRA 11.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| C093230 | fexofenadine |
| C569672 | N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide |
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| Allegra | Drug | A single oral dose of Allegra is dosed to subjects in combination with PF-03654746. |
|
| Allegra-D | Drug | A single oral dose of Allegra-D is dosed to subjects as an active comparator. |
|
| PF-03654746 | Drug | A single oral dose of PF-03654746 is the investigational drug being studied. |
|
| 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 |
| Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry | 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. | 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 |
| Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea | 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. | 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 |
| Nasal Symptom Scores: Sneezing | 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. | 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 |
| Randomized but not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
|
| Primary | Nasal Volume Proportion Measured Using Acoustic Rhinometry | 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. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | ratio | 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 |
|
|
|
|
| Secondary | Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry | 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. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | square centimeter (cm^2) | 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 |
|
|
|
|
| Secondary | Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry | 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. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | cubic centimeter (cm^3) | 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 |
|
|
|
|
| Secondary | Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea | 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. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
|
| Secondary | Nasal Symptom Scores: Sneezing | 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. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | sneezes | 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 |
|
|
|
|
| Other Pre-specified | Serum PF-03654746 Concentration | Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period. | Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 1 hr 30 min post dose on Day 1 of each intervention period |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | PF-03654746 1 mg | 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. | 0 | 19 | 2 | 19 |
| EG002 | 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. | 0 | 19 | 0 | 19 |
| EG003 | 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. | 0 | 19 | 2 | 19 |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
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.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. |
| ANOVA |
| 0.097 |
P-value was based on a one-sided test. There were no further adjustments for multiplicity. |
| 2-Sided |
| No |
| Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.252 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.479 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.521 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.952 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. |
| ANOVA |
| 0.663 |
P-value was based on a one-sided test. There were no further adjustments for multiplicity. |
| 2-Sided |
| No |
| Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.138 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.124 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.134 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.978 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. |
| ANOVA |
| 0.952 |
P-value was based on a one-sided test. There were no further adjustments for multiplicity. |
| 2-Sided |
| No |
| Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.480 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.043 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.087 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.753 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal congestion: Post-allergen challenge |
|
| Nasal congestion: Post-oxymetazoline |
|
| Nasal Itching: Pre-allergen challenge |
|
| Nasal Itching: Post-allergen challenge |
|
| Rhinorrhea: Pre-allergen challenge |
|
| Rhinorrhea: Post-allergen challenge |
|
Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. |
| ANOVA |
| 0.127 |
P-value was based on a one-sided test. There were no further adjustments for multiplicity. |
| 2-Sided |
| No |
| Superiority or Other |
| Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.103 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.218 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.905 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.273 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.000 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.055 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.012 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.048 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.496 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.190 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.000 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.019 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.009 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.061 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.778 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.102 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| Sneezing: Post-allergen challenge |
|
An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. |
| ANOVA |
| 0.000 |
P-value was based on a one-sided test. There were no further adjustments for multiplicity. |
| 2-Sided |
| No |
| Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.000 | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.217 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.156 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |
| An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | ANOVA | 0.848 | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | 2-Sided | No | Superiority or Other |