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The objectives of this enabling study are to characterize the wheal and flare responses over time following skin challenges with ascending concentrations of Substance P. This will be a 2-part study: Part 1 will aid in the understanding of the wheal and flare responses following Substance P. Part 2 will investigate the variability of the responses. Participants may be enrolled into Part 1 or Part 2, not both.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substance P challenge in Part 1 | Experimental | Eligible participants will receive control challenge with saline and histamine, followed by challenge with ascending concentrations of Substance P. Part 1 will include a single challenge visit. |
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| Substance P challenge in Part 2 | Experimental | Eligible participants will receive control challenge with saline and histamine, followed by challenge with ascending concentrations of Substance P. Part 2 will include two challenge visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Substance P | Drug | Participants will receive Substance P |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P (SP) was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 picomoles (pmol) during the 2 hours post-challenge period. | 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) |
| Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Wheal area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Leiden | 2333 CL | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37547990 | Background | Ten Voorde W, Akinseye C, Abdisalaam I, Wind S, Klarenbeek N, Bergmans M, van Doorn M, Rissmann R, Kaur R, Hotee S, Foster K, Nair A, Fortunato L, Macphee C, Mole S, Baumann K, Brigandi R. Intradermal substance P as a challenge agent in healthy individuals. Clin Transl Sci. 2023 Oct;16(10):1856-1865. doi: 10.1111/cts.13592. Epub 2023 Aug 7. |
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Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 32 participants were enrolled (Enrolled population: All participants in the screened population who entered the study) in Part 1 (12 participants) and Part 2 (20 participants) of the study.
This was an open label, 2-part, sequential, prospective enabling study of Substance P (SP) intradermal challenge in healthy participants conducted at a single center in the Netherlands.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1- Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole [PMOL]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1. |
| FG001 | Part 1- No Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants whose wheal responses did not meet the acceptable saline and histamine response within 20 minutes of each control challenge or who were withdrawn from the study, independent of the wheal response acceptability, were not administered Substance P. |
| FG002 | Part 2- Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Up to Day 1) |
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| Part 2 (Up to 3 Weeks) |
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Baseline characteristics were presented for Enrolled population which consisted of all participants in the screened population who entered the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1- Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole [PMOL]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part 1: Wheal Response-time Area Under the Curve (AUC) Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P (SP) was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 picomoles (pmol) during the 2 hours post-challenge period. | Safety Population consisted of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Millimeter square*minutes | 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) |
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All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 1 for Part 1 and Up to Week 3 for Part 2.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants in the enrolled analysis set who received at least one challenge-related study procedure on their (first) challenge day. AEs were not collected for "Part 1:No Skin Challenges" arm (N=3), as they did not receive any challenge related study procedure, hence were not included in Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1- Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole [PMOL]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Reponse Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2020 | Jun 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | Jun 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013373 | Substance P |
| D000077330 | Saline Solution |
| D006632 | Histamine |
| ID | Term |
|---|---|
| D015320 | Tachykinins |
| D007705 | Kinins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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Parts 1 and 2 will run sequentially. Part 1 will include 1 challenge visit; Part 2 will include two challenge visits.
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It is an open-label study.
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| Normal Saline | Drug | Participants will receive normal saline as Negative control |
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| Histamine | Drug | Participants will receive histamine as Positive control |
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| 2 hours post-challenge on Day 1 (Visit 1) |
| Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Wheal area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2) |
| Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) |
| Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2) |
| Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) |
| Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2) |
| Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) |
| Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response variable was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2) |
| Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Flare area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) |
| Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Flare area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2) |
| Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) |
| Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2) |
| Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to complete flare area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for flare area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) |
| Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to complete flare area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2) |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)- Substance P Only | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs is presented. | Up to Day 1 |
| Part 2: Number of Participants With Non-serious AEs and SAEs- Substance P Only | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs is presented. | Up to 3 weeks |
| Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) | Vital signs parameters including Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate were measured in a semi-supine position after 5 minutes of rest with a completely automated device. PCI ranges were: SBP (Lower: less than [<]85 and Upper: greater than [>]160 millimeters of mercury [mmHg]); DBP (Lower: <45 and Upper: >100 mmHg); Heart Rate: (Lower: <40 and Upper: >110 beats per minute). Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1, including those from unscheduled visits. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages (%) may not add to 100%. | At Day 1 (Visit 1) |
| Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Vital signs parameters including SBP, DBP and heart rate were measured in a semi-supine position after 5 minutes of rest with a completely automated device. PCI ranges were: SBP (Lower: <85 and Upper: >160 mmHg); DBP (Lower: <45 and Upper: >100 mmHg); Heart Rate: (Lower: <40 and Upper: >110 beats per minute). Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1 and challenge visit 2, including those from unscheduled visits. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the % may not add to 100%. | At Day 1 (Visit 1) and Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophil count, platelet count and white blood cell count. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameters: Basophils, eosinophils, lymphocytes, monocytes, total neutrophil count, platelet count and white blood cell count. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameter: Hemoglobin- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Hemoglobin. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameter: Hemoglobin- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Hemoglobin. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameter: Hematocrit- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Hematocrit. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameter: Hematocrit- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Hematocrit. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle hemoglobin. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle hemoglobin. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle volume. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle volume. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Red blood cell count. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Red blood cell count. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Hematology Parameter: Reticulocyte- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Reticulocyte. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Hematology Parameter: Reticulocyte- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Reticulocyte. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: Alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameters: Alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: Total Bilirubin and creatinine. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameters: Total bilirubin and creatinine. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: Calcium, glucose, potassium, sodium, and urea/BUN. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameters: Calcium, glucose, potassium, sodium, and urea/BUN. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Change From Baseline in Clinical Chemistry Parameter: Total Protein- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameter: Total protein. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
| Part 2: Change From Baseline in Clinical Chemistry Parameter: Total Protein- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameter: Total protein. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
| Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) | Urine samples were collected for the analysis of urinalysis parameters: Occult blood, glucose, ketones and protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters indicate proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'Any increase' if there was any increase in their urine concentrations compared to Baseline. Participants whose value was unchanged or whose value was decreased, were recorded in the 'No change/Decreased' category. Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1, including those from unscheduled visits. | At Day 1 (Visit 1) |
| Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2) | Urine samples were collected for the analysis of urinalysis parameters: Occult blood, glucose, ketones and protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters indicate proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'Any increase' if there was any increase in their urine concentrations compared to Baseline. Participants whose value was unchanged or whose value was decreased, were recorded in the 'No change/Decreased' category. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. | At Week 2 (Visit 2) |
| Part 1: Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) Findings- Substance P Only at Challenge Visit 1 (Day 1) | 12-lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal, clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | At Day 1 (Visit 1) |
| Part 2: Number of Participants With Clinically Significant Abnormal 12-lead ECG Findings- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | 12-lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal, CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | At Day 1 (Visit 1) and Week 2 (Visit 2) |
| Withdrawal by Subject |
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| Number of Participants Who Received SP 15 PMOL |
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| Number of Participants Who Received SP 50 PMOL |
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| Number of Participants Who Received SP 150 PMOL |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Part 1- No Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants whose wheal responses did not meet the acceptable saline and histamine response within 20 minutes of each control challenge or who were withdrawn from the study, independent of the wheal response acceptability, were not administered Substance P. |
| BG002 | Part 2- Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses, were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50, 150 and 500 picomole [PMOL]) at challenge visit 1 (Day 1) and wheal and flare responses were assessed. There was no Challenge Visit 2 in Part 1. |
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| Primary | Part 2: Wheal Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Wheal response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The wheal response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population | Posted | Mean | Standard Deviation | Millimeter square*minutes | 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2) |
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| Secondary | Part 1: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Wheal area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Millimeter square | 2 hours post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Wheal area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population | Posted | Mean | Standard Deviation | Millimeter square | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2) |
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| Secondary | Part 1: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Time to Maximum Observed Wheal Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to maximum observed wheal area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2) |
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| Secondary | Part 1: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Time to Complete Wheal Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to complete wheal area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge at Week 2 (Visit 2) |
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| Secondary | Part 1: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. Zeros reported reflect measured data derived during analysis. | Posted | Mean | Standard Deviation | Millimeter square*minutes | 0, 5, 10, 15, 20, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Flare Response-time AUC Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Flare response-time AUC during the 2 hours post-challenge period following skin challenge for Substance P was calculated using the trapezoidal rule. The flare response variable was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population. Zeros reported reflect measured data derived during analysis. | Posted | Mean | Standard Deviation | Millimeter square*minutes | 0, 5, 10, 15, 20, 30, 40, 60, 90 and 120 minutes post-challenge on Day 1 (Visit 1) and on Week 2 (Visit 2) |
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| Secondary | Part 1: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Flare area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. Zeros reported reflect measured data derived during analysis. | Posted | Mean | Standard Deviation | Millimeter square | 2 hours post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P Across- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Flare area was calculated using the following formula: 1/4 * pi * longest diameter * orthogonal diameter, for area of an ellipse, using the longest and orthogonal diameters measured by the calliper method. The maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population. Zeros reported reflect measured data derived during analysis. | Posted | Mean | Standard Deviation | Millimeter square | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2) |
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| Secondary | Part 1: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Time to Maximum Observed Flare Area Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to maximum observed flare area was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2) |
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| Secondary | Part 1: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) | Time to complete flare area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for flare area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50, 150 and 500 pmol during the 2 hours post-challenge period. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) |
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| Secondary | Part 2: Time to Complete Flare Area Disappearance Over the 2 Hours Post-challenge Period Following Skin Challenge With Substance P- at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Time to complete flare area disappearance was calculated during the 2 hours post-challenge period. Complete disappearance is defined as a value of 0 for wheal area, longest diameter or orthogonal diameter. Participants who did not have a disappearance within the 2 hours post challenge period were excluded. Time to complete wheal area disappearance was calculated for each control challenge (saline and histamine) and each ascending Substance P concentration: 5, 15, 50 and 150 pmol during the 2 hours post-challenge period. | Safety Population | Posted | Median | Full Range | Minutes | 2 hours post-challenge on Day 1 (Visit 1) and 2 hours post-challenge At Week 2 (Visit 2) |
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| Secondary | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)- Substance P Only | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs is presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 1 |
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| Secondary | Part 2: Number of Participants With Non-serious AEs and SAEs- Substance P Only | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs is presented. | Safety Population | Posted | Count of Participants | Participants | Up to 3 weeks |
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| Secondary | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) | Vital signs parameters including Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate were measured in a semi-supine position after 5 minutes of rest with a completely automated device. PCI ranges were: SBP (Lower: less than [<]85 and Upper: greater than [>]160 millimeters of mercury [mmHg]); DBP (Lower: <45 and Upper: >100 mmHg); Heart Rate: (Lower: <40 and Upper: >110 beats per minute). Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1, including those from unscheduled visits. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages (%) may not add to 100%. | Safety Population. | Posted | Count of Participants | Participants | At Day 1 (Visit 1) |
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| Secondary | Part 2: Number of Participants With Worst Case Vital Signs Parameter Results by Potential Clinical Importance (PCI) Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | Vital signs parameters including SBP, DBP and heart rate were measured in a semi-supine position after 5 minutes of rest with a completely automated device. PCI ranges were: SBP (Lower: <85 and Upper: >160 mmHg); DBP (Lower: <45 and Upper: >100 mmHg); Heart Rate: (Lower: <40 and Upper: >110 beats per minute). Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1 and challenge visit 2, including those from unscheduled visits. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the % may not add to 100%. | Safety Population | Posted | Count of Participants | Participants | At Day 1 (Visit 1) and Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophil count, platelet count and white blood cell count. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Giga cells per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophil Count, Platelet Count and White Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameters: Basophils, eosinophils, lymphocytes, monocytes, total neutrophil count, platelet count and white blood cell count. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Giga cells per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Hemoglobin. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Hemoglobin. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Hematocrit- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Hematocrit. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Hematocrit- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Hematocrit. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle hemoglobin. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle hemoglobin. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Picograms | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle volume. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Mean corpuscle volume. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Red blood cell count. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Red blood cell count. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Reticulocyte- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of hematology parameter: Reticulocyte. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed | Posted | Mean | Standard Deviation | Percentage of reticulocytes | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Reticulocyte- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of hematology parameter: Reticulocyte. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Percentage of reticulocytes | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: Alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameters: Alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: Total Bilirubin and creatinine. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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|
| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameters: Total bilirubin and creatinine. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: Calcium, glucose, potassium, sodium, and urea/BUN. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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|
|
| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, and Urea/BUN- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameters: Calcium, glucose, potassium, sodium, and urea/BUN. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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|
|
| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameter: Total Protein- Substance P Only at Challenge Visit 1 (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameter: Total protein. Baseline value is defined as the latest non-missing pre-first control challenge assessment value (Within 1 hour before first control challenge) at challenge visit 1, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 1: pre-dose) and At Day 1 (Visit 1) |
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| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameter: Total Protein- Substance P Only at Challenge Visit 2 (Week 2) | Blood samples were collected for the analysis of clinical chemistry parameter: Total protein. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 1: pre-dose) and At Week 2 (Visit 2) |
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| Secondary | Part 1: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 1 (Day 1) | Urine samples were collected for the analysis of urinalysis parameters: Occult blood, glucose, ketones and protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters indicate proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'Any increase' if there was any increase in their urine concentrations compared to Baseline. Participants whose value was unchanged or whose value was decreased, were recorded in the 'No change/Decreased' category. Baseline value is defined as the latest non-missing pre-first control challenge assessment value at challenge visit 1, including those from unscheduled visits. | Safety Population. | Posted | Count of Participants | Participants | At Day 1 (Visit 1) |
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| Secondary | Part 2: Number of Participants With Worst Case Urinalysis Parameters Post-Baseline Relative to Baseline- Substance P Only at Challenge Visit 2 (Week 2) | Urine samples were collected for the analysis of urinalysis parameters: Occult blood, glucose, ketones and protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters indicate proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'Any increase' if there was any increase in their urine concentrations compared to Baseline. Participants whose value was unchanged or whose value was decreased, were recorded in the 'No change/Decreased' category. For Part 2, the Baseline for Visit 2 is defined as the latest assessment performed after Visit 1 visits (such as Unscheduled) but before the first Visit 2 challenge. | Safety Population | Posted | Count of Participants | Participants | At Week 2 (Visit 2) |
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| Secondary | Part 1: Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) Findings- Substance P Only at Challenge Visit 1 (Day 1) | 12-lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal, clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population. | Posted | Count of Participants | Participants | At Day 1 (Visit 1) |
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| Secondary | Part 2: Number of Participants With Clinically Significant Abnormal 12-lead ECG Findings- Substance P Only at Challenge Visit 1 (Day 1) and Challenge Visit 2 (Week 2) | 12-lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal, CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety Population | Posted | Count of Participants | Participants | At Day 1 (Visit 1) and Week 2 (Visit 2) |
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|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Part 2- Skin Challenges | Healthy participants were first administered saline, by intradermal injection, and histamine by skin prick, as negative and positive controls. Participants with acceptable saline and histamine responses were administered up to 4 intradermal injections of Substance P sequentially from lowest to highest concentration (5, 15, 50 and 150 PMOL) and wheal and flare responses were assessed along with Intradermal microdialysis (IDM) after Challenge Visit 1 (Day 1). At Challenge Visit 2 (Week 2), participants were administered up to 6 Substance P intradermal injections and wheal and flare response, IDM and biopsies were taken (one from each challenged site and one from a non-challenged area of skin. | 0 | 20 | 0 | 20 | 2 | 20 |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005021 | Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge on Day 1 |
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
|
| SP 5 pmol |
|
|
| SP 15 pmol |
|
|
| SP 50 pmol |
|
|
| SP 150 pmol |
|
|
| SP 500 pmol |
|
|
|
| Histamine: 2 hours post-challenge at Week 2 |
|
| SP 5 pmol: 2 hours post-challenge on Day 1 |
|
| SP 5 pmol: 2 hours post-challenge at Week 2 |
|
| SP 15 pmol: 2 hours post-challenge on Day 1 |
|
| SP 15 pmol: 2 hours post-challenge at Week 2 |
|
| SP 50 pmol: 2 hours post-challenge on Day 1 |
|
| SP 50 pmol: 2 hours post-challenge at Week 2 |
|
| SP 150 pmol:2 hours post-challenge on Day 1 |
|
| SP 150 pmol: 2 hours post-challenge at Week 2 |
|
| Title | Measurements |
|---|---|
|
| DBP: To low |
|
| DBP: To within range or no Change |
|
| DBP: To High |
|
| Heart rate: To low |
|
| Heart rate: To within range or no Change |
|
| Heart rate: To High |
|
| Title | Measurements |
|---|---|
|
| SBP: To low, Week 2 |
|
| SBP: To within range or no Change, Week 2 |
|
| SBP: To High, Week 2 |
|
| DBP: To low, Day 1 |
|
| DBP: To within range or no Change, Day 1 |
|
| DBP: To High, Day 1 |
|
| DBP: To low, Week 2 |
|
| DBP: To within range or no Change, Week 2 |
|
| DBP: To High, Week 2 |
|
| Heart rate: To low, Day 1 |
|
| Heart rate: To within range or no Change, Day 1 |
|
| Heart rate: To High, Day 1 |
|
| Heart rate: To low, Week 2 |
|
| Heart rate: To within range or no Change,Week 2 |
|
| Heart rate: To High, Week 2 |
|
| Title | Measurements |
|---|---|
|
| Monocytes |
|
| Total neutrophil count |
|
| Platelet count |
|
| White blood cell count |
|
| Title | Measurements |
|---|---|
|
| Monocytes |
|
| Total neutrophil count |
|
| Platelet count |
|
| White blood cell count |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Sodium |
|
| Urea/BUN |
|
| Title | Measurements |
|---|---|
|
| Sodium |
|
| Urea/BUN |
|
| Title | Measurements |
|---|---|
|
| Glucose: Any increase |
|
| Ketones No change/decreased |
|
| Ketones: Any increase |
|
| Protein: No change/decreased |
|
| Protein: Any increase |
|
| Title | Measurements |
|---|---|
|
| Glucose: Any increase |
|
| Ketones No change/decreased |
|
| Ketones: Any increase |
|
| Protein: No change/decreased |
|
| Protein: Any increase |
|