A Phase 2 interventional study of Pollen allergen extract in Asthma and Rhinitis, sponsored by GlaxoSmithKline. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 16 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Investigator discretion will be used regarding exacerbations that have resolved since screening visit.
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.
Other: Pollen allergen extract
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
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.
Time frame: Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
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.
| Milestone | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Started | 6 | 10 |
| Completed | 6 | 10 |
| Not completed | 0 | 0 |
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.
| Score on a scale | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min) | 3.8 (1.22 to 6.53) | 5.9 (3.91 to 7.81) |
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.
| Score on a scale | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Mean Change From Baseline in the TNSS Over Post-NAC 1 h | 2.4 (0.24 to 4.63) | 3.4 (1.70 to 4.96) |
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.
| Score on a scale | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Mean Change From Baseline in the TNSS Over Post-NAC 6 h | 1.2 (0.04 to 2.33) | 1.6 (0.73 to 2.44) |
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.
| Score on a scale | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h | 4.1 (1.41 to 6.80) | 5.9 (3.83 to 7.87) |
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.
| Percent change | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min | 27.6 (15.87 to 39.63) | 32.2 (23.71 to 40.72) |
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.
| Percent change | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Percent Change From Baseline in the PNIF Over Post-NAC 1 h | 20.8 (5.45 to 35.84) | 25.0 (14.69 to 36.05) |
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.
| Percent change | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Percent Change From Baseline in the PNIF up to Post-NAC 6 h | 6.3 (-7.56 to 20.47) | 7.3 (-2.98 to 17.68) |
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.
| Percent change | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h | 33.3 (16.89 to 49.33) | 39.9 (29.18 to 51.53) |
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.
| Score on a scale | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Sneezing, 15 min | 1.33 ± 1.366 | 1.50 ± 1.080 |
| Sneezing, WM 0-1 h | 0.56 ± 0.706 | 0.56 ± 0.641 |
| Sneezing, WM 0-6 h | 0.40 ± 0.496 | 0.19 ± 0.463 |
| Sneezing, Max 0-6 h | 1.33 ± 1.366 | 1.60 ± 1.075 |
| Rhinorrhoea, 15 min | 0.50 ± 0.548 | 1.60 ± 1.075 |
| Rhinorrhoea, WM 0-1 h | 0.15 ± 0.300 | 1.16 ± 0.924 |
| Rhinorrhoea, WM 0-6 h | -0.06 ± 0.383 | 0.60 ± 0.791 |
| Rhinorrhoea, Max 0-6 h | 0.50 ± 0.548 | 1.60 ± 1.075 |
| Nasal itching , 15 min | 0.67 ± 1.033 | 1.50 ± 0.850 |
| Nasal itching , WM 0-1 h | 0.44 ± 0.832 | 1.15 ± 0.733 |
| Nasal itching , WM 0-6 h | 0.05 ± 0.684 | 0.60 ± 0.556 |
| Nasal itching , Max 0-6 h | 0.83 ± 0.753 | 1.60 ± 0.843 |
| Nasal blockage , 15 min | 1.17 ± 0.753 | 1.70 ± 0.675 |
| Nasal blockage , WM 0-1 h | 0.73 ± 0.533 | 1.26 ± 0.641 |
| Nasal blockage , WM 0-6 h | 0.43 ± 0.485 | 0.64 ± 0.500 |
| Nasal blockage , Max 0-6 h | 1.33 ± 0.816 | 1.80 ± 0.632 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Once Weekly | — | 0/6 (0%) | 1/6 (16.7%) |
| GSK2245035 20 ng, i.n., Once Weekly | — | 0/10 (0%) | 0/10 (0%) |
| Event | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly |
|---|---|---|
| Urinary tract infectionInfections and infestations | 1/6 | 0/10 |
| Diabetes mellitusMetabolism and nutrition disorders | 1/6 | 0/10 |
| Age, Continuous(Years) | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly | Total |
|---|---|---|---|
| Mean | 41.3 ± 12.82 | 40.4 ± 12.02 | 40.8 ± 11.90 |
| Sex: Female, Male(Participants) | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly | Total |
|---|---|---|---|
| Female | 4 | 8 | 12 |
| Male | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Placebo Once Weekly | GSK2245035 20 ng, i.n., Once Weekly | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 10 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: Yes — 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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