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The purpose of this study is to examine the safety and effects on the immune system of treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to pollen or perennial allergen, with or without mild asthma. In addition, the effect of treatment with GSK2245035 on the body's allergic response in test situations will be explored. Approximately 28 subjects will receive GSK2245035 (up to 14 subjects each receiving 80 nanograms [ng] GSK2245035 and up to 14 subjects each receiving 20 ng GSK2245035) and 14 subjects will receive the dummy drug (placebo) during the study. Assignment of a subject to GSK2245035 or placebo will be done by chance, like flipping a coin. Neither the subjects nor the clinic staff will know whether a subject is being dosed with GSK2245035 or placebo during the course of the study. The study will include (a) Screening phase where the eligibility of subjects for enrolment will be assessed (b) Treatment phase during which subjects will receive either 8 nasal sprays of GSK2245035 80 ng or a matching placebo once weekly for 8 weeks (each dose will be split between the two nostrils). Subjects participating in this study in 2014 will receive a reduced dose of 20 ng i.n. of GSK2245035 once weekly for eight administrations (c) Follow-up period where any GSK2245035 induced changes to the immune system and the effect of treatment on the body's allergic response in test situations will be monitored. The maximum planned study duration for all subjects, including the screening, treatment and follow-up periods, is approximately 180 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2245035 Arm | Experimental | Subjects participating prior to 2014 will receive i.n GSK2245035 80 ng once weekly for 8 weeks (each dose will be split between the two nostrils). Subjects participating in 2014 will receive i.n GSK2245035 20 ng once weekly for 8 weeks (each dose will be split between the two nostrils). |
|
| Placebo Arm | Placebo Comparator | Subjects will receive i.n placebo once weekly for 8 weeks (each dose will be split between the two nostrils) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2245035 | Drug | Nasal spray solution, to be given intranasal, 80 ng/20 ng once weekly for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by number of subjects with adverse events | Up to 180 days | |
| Safety assessed by measurement of body temperature | The measurement of body temperature with an automatic thermometer placed in the subject's mouth will be performed by the research unit staff when a subject is in the unit and by the individual when a subject is not in the unit | Up to 180 days |
| Safety assessed by lung function measurements | Spirometry will be performed at screening and Peak Expiratory Flow will be measured at all other planned time points | Up to 180 days |
| Safety assessed by measurement of clinical laboratory parameters | Hematology, clinical chemistry, urinalysis and additional parameters to be tested | Up to 180 days |
| Nasal examination for assessment of nasal tolerability | Visual examination of the nose will be done to assess the color of mucosa, degree of turbinate swelling, presence/description of any secretion, presence/absence of infection, post-nasal drip, crusting, signs of bleeding and any other signs of irritancy | Up to 180 days |
| Nasal symptoms monitoring for assessment of nasal tolerability | Nasal tolerability will be assessed using a Visual analogue scale scoring system. Subjects will be asked to respond to various statements of a questionnaire by placing a small vertical mark on a horizontal line, 10 centimeters in length, with a statement placed at each end of the line. Nasal symptoms of rhinorrhea, blockage, itchiness, soreness or dryness and modification of the sense of taste/smell will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2017 | |
| Reset | May 5, 2017 | |
| Release | Oct 15, 2017 |
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| Placebo | Drug | Nasal Spray Solution, to be given intranasal, once weekly for 8 weeks |
|
| Up to 7 weeks (Dosing Visits 1 to 8) |
| Measurement of TLR7-induced blood Pharmacodynamic (PD) biomarkers, including TLR7-induced cytokines | Blood samples will be collected to measure levels of TLR7-induced soluble biomarkers and/or allergic blood biomarkers, including but not limited to immunoglobulins | Up to 180 days (Screening Allergen Challenge Visit 2, Dosing Visits 1 and 8, Follow-up Allergen Challenge Visits |
| Measurement of TLR7-induced nasal PD biomarkers, including but not limited to Interferon gamma-induced protein 10 (IP-10) measurement in nasal fluid | During allergen challenge visits, nasal lavage samples will be collected from one nostril only; nasal filters will be inserted in the other nostril and will remain there for 5 minutes | Up to 180 days (Screening Allergen Challenge Visit 2, Dosing Visits 1 and 8, Follow-up Allergen Challenge Visits |
| Unrelease | Yes |
| Release | Mar 8, 2018 |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2017 | May 5, 2017 | |||
| Oct 15, 2017 | Yes | |||
| Mar 8, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000603511 | GSK2245035 |
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