Page last updated: 2024-10-21

urea and Hay Fever

urea has been researched along with Hay Fever in 6 studies

pseudourea: clinical use; structure
isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives.

Research Excerpts

ExcerptRelevanceReference
" SB-705498 was well tolerated and pharmacokinetics exposure results supported the dosing regimen."2.78The effects of a TRPV1 antagonist, SB-705498, in the treatment of seasonal allergic rhinitis. ( Bareille, P; Bentley, J; Denyer, J; Horak, F; Lemell, P; Murdoch, RD; Smart, K; Yarnall, K; Zieglmayer, P; Zieglmayer, R, 2013)
"The urea method was found to be useful as a dilution marker for nasal lavage fluid."2.69[Usefulness of the urea method in nasal discharge analysis]. ( Sakata, K, 2000)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19902 (33.33)18.7374
1990's1 (16.67)18.2507
2000's1 (16.67)29.6817
2010's2 (33.33)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Bareille, P1
Murdoch, RD1
Denyer, J1
Bentley, J1
Smart, K1
Yarnall, K1
Zieglmayer, P1
Zieglmayer, R1
Lemell, P1
Horak, F1
Alenmyr, L1
Greiff, L1
Andersson, M1
Sterner, O1
Zygmunt, PM1
Högestätt, ED1
Norman, PS1
Ishizaka, K1
Lichtenstein, LM2
Adkinson, NF1
Sakata, K1
Liu, MC1
Hubbard, WC1
Proud, D1
Stealey, BA1
Galli, SJ1
Kagey-Sobotka, A1
Bleecker, ER1
Paskova, Z1
Hodek, B1
Miklikova, Z1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-blind, Placebo Controlled, Incomplete Block, 3 Way Cross Over Study in Subjects With Allergic Rhinitis to Assess the Effect of Intranasal Repeat Doses of SB-705498 When Administered Alone or in Conjunction With Intranasal Fluticasone [NCT01424397]Phase 270 participants (Actual)Interventional2011-04-14Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Area Under Concentration-time Curve (AUC) for SB-705498 on Day 8

Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV. (NCT01424397)
Timeframe: Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)

Interventionnanograms*hour per mililiter (ng.h/mL) (Geometric Mean)
SB-705498 12 mg588.26
SB-705498 + FP 12 mg608.84

Change From Baseline in ECG Values: Heart Rate

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, and QTc intervals. Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value. (NCT01424397)
Timeframe: Baseline and Day 8 of each treatment period

Interventionbeats per minute (bpm) (Mean)
Placebo-0.2
FP 200 μg-4.7
SB-705498 12 mg-4.8
SB-705498 + FP 12 mg-2.6

Maximum Observed Concentration (Cmax) for SB-705498 on Day 8

Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as least squares geometric means with respective geometric coefficient of variation (% CV). (NCT01424397)
Timeframe: Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)

Interventionnanograms per mililiter (ng/mL) (Geometric Mean)
SB-705498 12 mg145.958
SB-705498 + FP 12 mg154.231

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 or or SB-705498 Matching Placebo

The RQLQ composed of 28 items covering 7 domains of health. Each question is scored on a scale of 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). 7 domains were: Activities (3 items):1, 2, 3;Sleep (3 items): 4, 5, 6; Non-nose/eye symptoms (7 items): 7, 8, 9, 10, 11, 12, 13; Practical Problems (3 items): 14, 15, 16; Nasal Symptoms (4 items): 17, 18, 19, 20; Eye Symptoms (4 items): 21, 22, 23, 24; Emotional (4 items): 25, 26, 27, 28 consisted of total 28 items. Domain activity score = total post-baseline score for individualized activity items answered on both visits divided by total Baseline score for individualized activity items answered on both visits multiplied by the Baseline score for item(s) missing post-baseline. The global RQLQ score was calculated by averaging all 28 item scores, which ranges from 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). Higher scores indicate worsening of symptoms. (NCT01424397)
Timeframe: Day 8

InterventionScore on a scale (Least Squares Mean)
Placebo1.67
FP 200 μg0.99
SB-705498 12 mg1.66
SB-705498 + FP 12 mg1.14

Total Nasal Airflow on Day 8 Measured Using Active Anterior Rhinomanometry (AAR)

Total Nasal Airflow is calculated as the sum of the left nostril and the right nostril airflow values. AAR is a very sensitive method of assessing clinical parameters of nasal obstruction (nasal flow, nasal resistance and nasal flow increase). A participant was instructed to breathe through one nostril while a sensor in the other nostril measured the difference in pre-nasal and choanal pressure. The system was connected to a computer. Nasal flow and nasal resistance were observed at pressure levels of 75, 150 and 300 Pascal. The defined measuring range for the flow was +-1000 milliliter per second (mL/s). Weighted means for total nasal airflow Resistance was calculated by dividing the area under the curve between 1 and 4 hours (via the linear trapezoidal method) by the total duration that the participant took to complete the chamber challenge assessments. (NCT01424397)
Timeframe: Day 8

InterventionMilliliters per second (mL/s) (Least Squares Mean)
Placebo306.99
FP 200 μg388.34
SB-705498 12 mg299.68
SB-705498 + FP 12 mg379.40

Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, QTc corrected by Bazett's formula (QTcB) and QTc corrected by Fridericia's formula (QTcF). Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value. (NCT01424397)
Timeframe: Baseline and Day 8 of each treatment period

,,,
InterventionMilliseconds (msec) (Mean)
PR IntervalQRS DurationQT IntervalQTcBQTcF
FP 200 μg-1.22.24.6-9.3-4.4
Placebo2.70.8-1.5-3.6-2.9
SB-705498 + FP 12 mg0.4-0.22.5-4.1-1.9
SB-705498 12 mg4.50.8-0.3-13.9-9.0

Mean TNSS and Its Individual Components From Day 4 to Day 8

Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Mean of TNSS and its individual components is presented pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8. (NCT01424397)
Timeframe: pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8 of each treatment period

,,,
InterventionScore on a scale (Mean)
TNSS,Day 4, pre-pm doseTNSS,Day 5, pre-pm doseTNSS,Day 6, pre-pm doseTNSS,Day 7, pre-pm doseTNSS,Day 8, pre-challenge (1hr)Nasal congestion score code,Day 4, pre-pm doseNasal congestion score code,Day 5, pre-pm doseNasal congestion score code,Day 6, pre-pm doseNasal congestion score code,Day 7, pre-pm doseNasal congestion score code,Day 8, pre-challengeRhinorrhoea score code,Day 4, pre-pm doseRhinorrhoea score code,Day 5, pre-pm doseRhinorrhoea score code,Day 6, pre-pm doseRhinorrhoea score code,Day 7, pre-pm doseRhinorrhoea score code,Day 8, pre-challenge (1hr)Nasal itching score code,Day 4, pre-pm doseNasal itching score code,Day 5, pre-pm doseNasal itching score code,Day 6, pre-pm doseNasal itching score code,Day 7, pre-pm doseNasal itching score code,Day 8, pre-challenge (1hrSneezing score code,Day 4, pre-pm doseSneezing score code,Day 5, pre-pm doseSneezing score code,Day 6, pre-pm doseSneezing score code,Day 7, pre-pm doseSneezing score code,Day 8, pre-challenge (1hr)
FP 200 μg2.42.01.81.71.30.80.70.70.60.60.60.50.40.40.30.50.40.30.40.30.50.40.40.30.1
Placebo3.63.63.33.22.01.00.90.90.80.70.90.90.80.80.60.90.80.80.80.50.90.90.80.80.3
SB-705498 + FP 12 mg2.62.32.01.91.10.70.60.60.60.40.50.50.60.40.30.70.70.50.50.30.60.40.40.40.1
SB-705498 12 mg3.32.92.82.21.90.90.70.80.70.60.90.90.80.60.60.70.40.50.30.30.90.80.70.50.4

Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8

Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Weighted mean (WM) of TNSS and its individual components (nasal congestion, rhinorrhoea, itching and sneezing) are presented on Day 8. Weighted mean was calculated over the time interval 0 to 4 hours after start of allergen chamber challenge by calculating the area under the curve of TNSS/component from time of the first observation to time of the last observation (AUC [tf-t1 hours]) using the trapezoidal rule, and then dividing by the actual relevant time interval (tf-t1) required by participant to complete the chamber challenge assessments. A Bayesian analysis was conducted to derive the posterior probability for TNSS. (NCT01424397)
Timeframe: Day 8 of each treatment period

,,,
InterventionScore on scale (Mean)
TNSS WMNasal congestion scoreWMRhinorrhoea score WMNasal itching score WMSneezing score WM
FP 200 μg3.651.150.940.940.62
Placebo6.531.801.671.671.39
SB-705498 + FP 12 mg4.141.181.051.170.74
SB-705498 12 mg6.571.821.751.571.43

Number of Participants With Clinical Biochemistry Parameters of PCI

The PCC range for clinical chemistry parameters included albumin, low: 0.86, millimole per liter (mmol)/L, calcium, low: 0.91, high: 1.06, glucose. Low: 0.71, high: 1.41, Potassium, low: 0.86, high: 1.10, Sodium, low: 0.96, high: 1.03, Total CO2, Low: 0.86, high: 1.14, Creatinine, in male, Low: <75 micromole per liter (μmol/L), high: >110 μmol/L, female, Low: <65 μmol/L, high: >95, Blood Urea Nitrogen (BUN), high: >1.5xULN mmol/L, Uric Acid, in male, Low: < 180 μmol/L, high: > 480 μmol/L, female, Low: < 120 μmol/L, high: > 420. Only parameters with PCI values are reported. (NCT01424397)
Timeframe: Up to Week 16

,,,
InterventionParticipants (Count of Participants)
Creatinine,LowCreatinine,HighAspartate Amino Transferase,HighPotassium,HighUric acid,HighGamma Glutamyl Transferase,HighTotal Bilirubin,HighAlanine Amino Transferase,High
FP 200 μg252140112
Placebo192121110
SB-705498 + FP 12 mg142051110
SB-705498 12 mg61121210

Number of Participants With Hematology Parameters of PCI

The PCC range for hematology parameters included white blood cell count, low: 0.67, high 1.82, neutrophil count, low: 0.83, Hemoglobin, male- high 1.03, female- high 1.13, hematocrit, male- high 1.02, female- high 1.17, Platelet Count, low: 0.67, high: 1.57, lymphocytes, low 0.81. Only parameters with PCI values are reported. (NCT01424397)
Timeframe: Up to Week 16

,,,
InterventionParticipants (Count of Participants)
Total Neutrophils,lowHematocrit,highHemoglobin,high
FP 200 μg900
Placebo700
SB-705498 + FP 12 mg400
SB-705498 12 mg211

Number of Participants With Vital Signs of Potential Clinical Importance (PCI)

Vital signs assessment included heart rate, blood pressure, and temperature. Criteria for vital sign values meeting potential clinical concern included: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mm Hg), diastolic blood pressure (DBP) < 45 and > 100 mm Hg, temperature <36 and >37.5 Degree Celsius and heart Rate <40 and >110 beats per minute. Only parameters with PCI values are reported. (NCT01424397)
Timeframe: Up to Week 16

,,,
InterventionParticipants (Count of Participants)
Temperature,Low,period 3Temperature,Low,Follow up
FP 200 μg01
Placebo22
SB-705498 + FP 12 mg00
SB-705498 12 mg00

Trials

3 trials available for urea and Hay Fever

ArticleYear
The effects of a TRPV1 antagonist, SB-705498, in the treatment of seasonal allergic rhinitis.
    International journal of clinical pharmacology and therapeutics, 2013, Volume: 51, Issue:7

    Topics: Administration, Intranasal; Adult; Androstadienes; Anti-Allergic Agents; Austria; Cross-Over Studies

2013
Effect of mucosal TRPV1 inhibition in allergic rhinitis.
    Basic & clinical pharmacology & toxicology, 2012, Volume: 110, Issue:3

    Topics: Adult; Capsaicin; Cross-Over Studies; Double-Blind Method; Female; Fluorometry; HEK293 Cells; Humans

2012
[Usefulness of the urea method in nasal discharge analysis].
    Nihon Jibiinkoka Gakkai kaiho, 2000, Volume: 103, Issue:6

    Topics: Adult; Biomarkers; Histamine; Humans; Male; Nasal Lavage Fluid; Rhinitis, Allergic, Seasonal; Trees;

2000

Other Studies

3 other studies available for urea and Hay Fever

ArticleYear
Treatment of ragweed hay fever with urea-denatured antigen E.
    The Journal of allergy and clinical immunology, 1980, Volume: 66, Issue:4

    Topics: Antigens; DNA; Dose-Response Relationship, Immunologic; Female; Histamine Release; Humans; Immunoglo

1980
Immediate and late inflammatory responses to ragweed antigen challenge of the peripheral airways in allergic asthmatics. Cellular, mediator, and permeability changes.
    The American review of respiratory disease, 1991, Volume: 144, Issue:1

    Topics: Adult; Albumins; Antigens; Asthma; Bronchi; Bronchoalveolar Lavage Fluid; Bronchoconstriction; Cell

1991
[Experience with Lysenyl in allergology].
    Minerva medica, 1972, Sep-01, Volume: 63, Issue:60

    Topics: Adolescent; Adult; Aged; Asthma; Child; Chronic Disease; Conjunctivitis; Eczema; Ergolines; Female;

1972