Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05476484
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-02
First Post:
2022-06-29
Brief Title:
Comparative Real World Effectiveness of SQ Sublingual Immunotherapy SLIT-Tablets vs Controls in Allergic Rhinitis and Asthma
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
Comparative Real World Effectiveness of SQ Sublingual Immunotherapy SLIT-Tablets vs Controls in Allergic Rhinitis and Asthma - Outcomes From a Multinational Register Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
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:
To assess the impact of SQ SLIT-tablets SQ Grass SLIT-tablet and SQ HDM SLIT-tablet in Danish and Swedish allergic rhinitis AR patients with or without asthma between 2007-2020
Detailed Description:
Allergic rhinitis AR is an inflammatory disorder characterised by pruritus sneezing rhinorrhoea and nasal congestion It is one of the most common disorders worldwide with an estimated global prevalence of 10-30 AR is a chronic and progressive disease as the underlying respiratory allergy can progress into allergic asthma The prevalence of asthma in patients with AR is high and estimated between 10-40 The presence of AR commonly exacerbates asthma increasing the risk of asthma exacerbations emergency visits and hospitalisations for asthma
Recently the high-quality retrospective cohort REACT study ClinicalTrialgov NCT04125888 found that allergy immunotherapy AIT was associated with long-term reduction in AR medication use as well as significant reductions in both controller and reliever asthma medication and concurrent lower risk of asthma exacerbation and pneumonia in subjects with pre-existing asthma The SQ sublingual immunotherapy SLIT-tablets have robust evidence from randomised controlled trials RCTs but real-world evidence RWE is needed to complement the findings from RCTs by looking at eg longer time horizons and broader patient populations As the REACT study was not designed to specifically look at evidence-based AIT treatments like the SQ SLIT-tablets the real-world effectiveness of SQ SLIT tablets remain to be further elucidated
Recently the high-quality retrospective cohort REACT study ClinicalTrialgov NCT04125888 found that allergy immunotherapy AIT was associated with long-term reduction in AR medication use as well as significant reductions in both controller and reliever asthma medication and concurrent lower risk of asthma exacerbation and pneumonia in subjects with pre-existing asthma The SQ sublingual immunotherapy SLIT-tablets have robust evidence from randomised controlled trials RCTs but real-world evidence RWE is needed to complement the findings from RCTs by looking at eg longer time horizons and broader patient populations As the REACT study was not designed to specifically look at evidence-based AIT treatments like the SQ SLIT-tablets the real-world effectiveness of SQ SLIT tablets remain to be further elucidated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None