Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02288156
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2014-11-06
Brief Title:
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Chronic rhinitis is affecting more than 200 million people worldwide Its prevalence is estimated to be as high as 30 of the Western population Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms rhinorrhea nasal blockage nasal itching andor sneezing The cut-off point for defining rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than twelve weeks Chronic rhinitis can be divided into three major subgroups based on the knowledge of the major etiological factor infectious rhinitis allergic rhinitis and non-allergic non-infectious rhinitis in literature also referred to as nonallergic rhinitis Non-inferiority in efficacy of the two novel treatment regimes ie capsaicin nasal spray 001mM 2puffsnostrilday during 4 weeks and capsaicin nasal spray 0001mM 2puffsnostrilday during 4 weeks compared to the current treatment of capsaicin nasal spray 01mM 5day administered on a single day with regard to the change from baseline in VAS for major nasal symptom on week 4
Estimated placebo effect is 25
Estimated placebo effect is 25
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