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This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK835726 (10mg) | Active Comparator | 10mg oral dose |
|
| GSK1004723 (1000mcg) | Active Comparator | 1000mcg nasal spray solution |
|
| Cetirizine 10mg | Active Comparator | 10mg cetirizine as active comparator |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK835726 10mg | Drug | GSK835726 10mg tablet |
| |
| GSK1004723 1000mcg |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. | Day 3 of each treatment period (approximately up to 63 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22212854 | Background | Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112864 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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All participants had a diagnosis of seasonal allergic rhinitis and exhibited a moderate response to allergen challenge in the environmental challenge chamber (ECC) at Screening, defined as total nasal symptom score (TNSS) more than equal to (>=) 6.
From June-2009 to August-2009, total of 54 participants were randomized at one site in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Participants randomized to receive once daily GSK1004723 (1000 micrograms [µg]) nasal spray solution for 3 days or oral tablet of GSK835726 (10 milligram [mg]) or oral capsule of cetirizine (10 mg) or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants randomized to receive once daily GSK1004723 1000 µg nasal spray solution for 3 days or oral tablet of GSK835726 10 mg or oral capsule of cetirizine 10 mg or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. | The all subjects population was used defined as all participants who receive at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Day 3 of each treatment period (approximately up to 63 days) |
AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
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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 | Placebo | Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C558852 | GSK 835726 |
| C558853 | GSK 1004723 |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
GSK1004723 1000mcg nasal spray solution |
|
| Cetirizine 10mg | Drug | Cetirizine 10mg active comparator |
|
| placebo | Drug | placebo to match actives |
|
| Day 3 of each treatment period (approximately up to 63 days) |
| Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean. | Day 3 of each treatment period (approximately up to 63 days) |
| Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean. | Day 3 of each treatment period (approximately up to 63 days) |
| Mean Forced Expiratory Volume in 1 Second (FEV1) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes. | Day 3 of each treatment period (approximately up to 63 days) |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or is associated with liver injury and impaired liver function defined as: alanine aminotransferase >=3 times upper limit of normal (ULN), and total bilirubin >=2 times ULN or international normalized ratio more than 1.5. | approximately up to 63 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112864 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112864 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112864 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112864 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112864 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112864 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Placebo | Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
| OG001 | GSK1004723 1000 µg Once Daily | Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
| OG002 | GSK835726 10 mg Once Daily | Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
| OG003 | Cetirizine 10 mg Once Daily | Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. |
|
|
|
| Secondary | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. | All Subjects population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Day 3 of each treatment period (approximately up to 63 days) |
|
|
|
|
| Secondary | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean. | All Subjects population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Grams | Day 3 of each treatment period (approximately up to 63 days) |
|
|
|
|
| Secondary | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean. | All Subjects population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Day 3 of each treatment period (approximately up to 63 days) |
|
|
|
|
| Secondary | Mean Forced Expiratory Volume in 1 Second (FEV1) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes. | All Subjects population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects population. | Posted | Mean | Standard Deviation | Liters | Day 3 of each treatment period (approximately up to 63 days) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or is associated with liver injury and impaired liver function defined as: alanine aminotransferase >=3 times upper limit of normal (ULN), and total bilirubin >=2 times ULN or international normalized ratio more than 1.5. | All Subjects population. | Posted | Number | Participants | approximately up to 63 days |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 15 |
| 52 |
| EG001 | GSK1004723 1000 µg Once Daily | Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | 54 | 0 | 54 | 53 | 54 |
| EG002 | GSK835726 10 mg Once Daily | Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | 53 | 0 | 53 | 13 | 53 |
| EG003 | Cetirizine 10 mg Once Daily | Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 0 | 52 | 0 | 52 | 17 | 52 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA version | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA version | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA version | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version | Systematic Assessment |
|
| Forced expiratory volume decreased | Investigations | MedDRA version | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version | 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.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Rhinorrhoea |
|
| Nasal Itching |
|
| Sneezing |
|
| Mean Difference (Final Values) |
| -0.2 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -0.4 |
| -0.1 |
Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily. |
| Superiority or Other |
| Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.4 | -0.1 | Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.4 | -0.1 | Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.6 | -0.2 | Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.5 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.6 | -0.3 | Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.4 | -0.1 | Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.5 | -0.2 | Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.5 | -0.2 | Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.5 | -0.2 | Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.4 | -0.2 | Comparison of Sneezing between Placebo and GSK835726 10mg once daily. | Superiority or Other |
| Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.5 | -0.2 | Comparison of Sneezing between Placebo and Cetirizine 10mg once daily. | Superiority or Other |
| Mean Difference (Final Values) |
| -1.760 |
| Standard Error of the Mean |
| 0.4172 |
| 2-Sided |
| 95 |
| -2.584 |
| -0.936 |
| Superiority or Other |
| Mean Difference (Final Values) | -2.792 | Standard Error of the Mean | 0.4224 | 2-Sided | 95 | -3.626 | -1.957 | Superiority or Other |
| Mean Difference (Final Values) |
| -1.05 |
| Standard Error of the Mean |
| 0.305 |
| 2-Sided |
| 95 |
| -1.65 |
| -0.45 |
| Superiority or Other |
| Mean Difference (Final Values) | -1.07 | Standard Error of the Mean | 0.308 | 95 | -1.68 | -0.46 | Superiority or Other |
|
| FEV1,1 hour |
|
|
| FEV1,2 hour |
|
|
| FEV1,3 hour |
|
|
| FEV1,4 hour |
|
|
| FEV1,5 hour |
|
|
| FEV1,6 hour |
|
|
| Any SAE |
|