Ignite Creation Date:
2024-05-05 @ 11:49 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01424514
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2011-08-18
Brief Title:
SB705498 Proof of Concept Chamber Challenge in Subjects With Non Allergic Rhinitis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Double Blind Placebo Controlled 2 Way Cross Over Study in Adults With Non-allergic Rhinits to Evaluate the Effect of Once Daily Administration of Intranasal SB-705498 12mg for Two Weeks and the Response to a Chamber Challenge of Cold Dry Air
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the pharmacodynamic PD effects Total Symptom Score TSS and its individual components rhinorrhoea nasal congestion post-nasal drip of intranasal repeat dose SB-705498 in non-allergic rhinitis NAR patients elicited by a cold dry air challenge in an environmental exposure chamber EEC SB-705498 is a selective antagonist of the transient receptor potential vanilloid-1 TRPV1 ligand gated ion channel TRPV1 is a cation permeable ion channel that can be activated by several physiological factors such as heat protons pH osmotic stress eicosanoid derivatives anandamide and by products of inflammation such as histamine prostaglandins and bradykinin In the nose the local TRPV1 expressing sensory C-fibres are thought to play a key role in the development of nasal hyper-responsiveness to environmental provocateurs It has been proposed that blocking the nasal sensory nerve stimulation may control nasal hyper-responsiveness and therefore prevent the induction of rhinitis symptoms In this context preclinical evidence supports that targeting TRPV1 by SB-705498 may be an attractive option
In this study NAR patients will be randomised in a double blind placebo controlled cross over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily Whilst dosing at home subjects will record symptom scores to document their symptoms In addition during visits to the clinical unit acoustic rhinometry quality of life questionnaires and safety assessments will be monitored
In this study NAR patients will be randomised in a double blind placebo controlled cross over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily Whilst dosing at home subjects will record symptom scores to document their symptoms In addition during visits to the clinical unit acoustic rhinometry quality of life questionnaires and safety assessments will be monitored
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None