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This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by repeating a nasal allergen challenge (NAC) approximately one year after treatment in subjects from TL7116958. This is a single centre, single period study in subjects with respiratory allergy/allergies who completed the study TL7116958 in 2014 to investigate the long term effect of previous treatment with GSK2245035 compared with placebo on total nasal symptoms elicited by nasal allergen challenge. Subjects and staff will remain blinded to the treatment received in the TL7116958 study (GSK2245035 or placebo). The study will consist of a screening visit to assess eligibility criteria, a study period consisting of a single visit when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit at the discretion of the investigator 4-7 days following the allergen challenge. Eligible subjects will participate in this study for approximately70 days total from screening to follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal allergen challenge | Other | Subjects do not receive study medication in this study 204509. Subjects who carried from study TL7116958 treatment group GSK2245035 will undergo NAC with pollen allergen extract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pollen allergen extract | Other | Pollen (tree, grass or ragweed) allergen extracts will be provided by the research unit and diluted as required in normal saline. The specific pollen allergen extract that will be used for the nasal allergen challenge will be selected according to each subject's individual allergic sensitivity demonstrated in the previous study, TL7116958. If possible, extracts remaining from this study in 2014 will be used, provided they have not reached their expiry date. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min) | TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value. | Day 1 (Baseline [pre-NAC] and post-NAC 15 min) |
| Mean Change From Baseline in the TNSS Over Post-NAC 1 h | TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported. | Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h) |
| Mean Change From Baseline in the TNSS Over Post-NAC 6 h | TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. | Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
Investigator discretion will be used regarding exacerbations that have resolved since screening visit.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kingston | Ontario | K7L 2V7 | Canada |
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| 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 |
|---|---|---|---|
| 204509 | Dataset Specification | 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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Participants with respiratory allergy/allergies, with or without asthma, who completed the parent study TL7116958 in 2014 were enrolled to investigate the long term effect of previous treatment with GSK2245035 compared to placebo on total nasal symptoms (sym.) elicited by allergen challenge.
Participants (par) of All subjects population (ASP) from study TL7116958 who passed screening for study 204509 were used as safety population for this study. All outputs using information from study TL7116958 were analyzed using ASP and stand alone outputs for this study were analyzed using Safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Once Weekly | Participants were not administered with placebo during the current study (204509). Participants were subjected to nasal allergen challenge (NAC) at Visit 2 to investigate the long term effect of matching placebo, intranasal (i.n.), administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 hours (h) post NAC. |
| FG001 | GSK2245035 20 ng, i.n., Once Weekly | Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 nanograms (ng), i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post NAC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Once Weekly | Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC. |
| 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 | Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min) | TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value. | The Safety population consisted of members of the ASP of parent study TL7116958 who had passed screening for study 204509. | Posted | Median | 95% Confidence Interval | Score on a scale | Day 1 (Baseline [pre-NAC] and post-NAC 15 min) |
Serious adverse events (SAEs) were collected from participant's consent for participation in the study till follow-up contact (4 to 7 day post Visit 2). Adverse events (AEs) were collected from the start of Study Visit 2 NAC until the follow-up contact.
Safety population was used to record AEs and SAEs. No SAEs were reported in the study.
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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 Once Weekly | Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012220 | Rhinitis |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
| Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h | TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period. | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
| Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min | PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation. | Day 1 (Baseline [pre-NAC] and post-NAC 15 min) |
| Percent Change From Baseline in the PNIF Over Post-NAC 1 h | PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation. | Day 1 (Baseline [pre-NAC] to post-NAC 1 h) |
| Percent Change From Baseline in the PNIF up to Post-NAC 6 h | PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation. | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
| Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h | PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported. | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
| Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 204509 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 204509 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 204509 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 204509 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 204509 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 204509 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 |
| GSK2245035 20 ng, i.n., Once Weekly |
Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Placebo Once Weekly | Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC. |
| OG001 | GSK2245035 20 ng, i.n., Once Weekly | Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC. |
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| Primary | Mean Change From Baseline in the TNSS Over Post-NAC 1 h | TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported. | Safety population | Posted | Median | 95% Confidence Interval | Score on a scale | Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h) |
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|
| Primary | Mean Change From Baseline in the TNSS Over Post-NAC 6 h | TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. | Safety population | Posted | Median | 95% Confidence Interval | Score on a scale | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
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| Primary | Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h | TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period. | Safety population | Posted | Median | 95% Confidence Interval | Score on a scale | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
|
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|
| Primary | Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min | PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation. | Safety population | Posted | Median | 95% Confidence Interval | Percent change | Day 1 (Baseline [pre-NAC] and post-NAC 15 min) |
|
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| Primary | Percent Change From Baseline in the PNIF Over Post-NAC 1 h | PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation. | Safety population | Posted | Median | 95% Confidence Interval | Percent change | Day 1 (Baseline [pre-NAC] to post-NAC 1 h) |
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| Primary | Percent Change From Baseline in the PNIF up to Post-NAC 6 h | PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation. | Safety populaton | Posted | Median | 95% Confidence Interval | Percent change | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
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| Primary | Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h | PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported. | Safety population | Posted | Median | 95% Confidence Interval | Percent change | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
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| Secondary | Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch. | Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value. | Safety population | Posted | Mean | Standard Deviation | Score on a scale | Day 1 (Baseline [pre-NAC] to post-NAC 6 h) |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | GSK2245035 20 ng, i.n., Once Weekly | Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC. | 0 | 10 | 0 | 10 |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA |
|
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 |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Sneezing, WM 0-6 h |
|
| Sneezing, Max 0-6 h |
|
| Rhinorrhoea, 15 min |
|
| Rhinorrhoea, WM 0-1 h |
|
| Rhinorrhoea, WM 0-6 h |
|
| Rhinorrhoea, Max 0-6 h |
|
| Nasal itching , 15 min |
|
| Nasal itching , WM 0-1 h |
|
| Nasal itching , WM 0-6 h |
|
| Nasal itching , Max 0-6 h |
|
| Nasal blockage , 15 min |
|
| Nasal blockage , WM 0-1 h |
|
| Nasal blockage , WM 0-6 h |
|
| Nasal blockage , Max 0-6 h |
|