Clinical Trial Results:
The effects of allergen immunotherapy on anti-viral immunity in patients with allergic asthma
Summary
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EudraCT number |
2019-003261-18 |
Trial protocol |
DK |
Global end of trial date |
31 Oct 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Sep 2023
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First version publication date |
27 Sep 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VITAL
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04100902 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Respiratory Research Unit, Department of Respiratory Medicine, Bispebjerg University Hospital
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Sponsor organisation address |
Ebba Lunds Vej 48, Entr. 66, Copenhagen NV, Denmark, 2400
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Public contact |
Christian Woehlk, Dept. Respiratory and Infectious Diseases, Bispbjerg Hospital, Respiratory Research Unit, Dept. Respiratory and Infectious Diseases, Bispebjerg Hospital, DK, +45 53644292, cwoe0007@regionh.dk
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Scientific contact |
Christian Woehlk, Dept. Respiratory and Infectious Diseases, Bispbjerg Hospital, Respiratory Research Unit, Dept. Respiratory and Infectious Diseases, Bispebjerg Hospital, DK, +45 53644292, cwoe0007@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Oct 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Mar 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Oct 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the effects of allergen immunotherapy on anti-viral immunity in patients with allergic asthma. Main outcome is to investigate potentiale change in bronchial epithelial cells interferon secretion before and after 6 month of treatment with ACARIZAX or placebo.
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Protection of trial subjects |
Pseudoanonomised
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Feb 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 39
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Worldwide total number of subjects |
39
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EEA total number of subjects |
39
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
39
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients recruited via the respiratory outpatient clinic at Bispebjerg Hospital, Copenhagen, Denmark and via social media. | |||||||||||||||||||||
Pre-assignment
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Screening details |
As per investigators judgement | |||||||||||||||||||||
Period 1
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Period 1 title |
Intervention (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||||||||||||||
Blinding implementation details |
Since both Acarizax and placebo are relabelled at the central pharmacy according to a randomization code, the investigational product will be received blinded to the study site.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Active | |||||||||||||||||||||
Arm description |
SQ HDM-SLIT | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
ACARIZAX® 12 SQ oral lyophilisate
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Investigational medicinal product code |
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Other name |
ODACTRA®, MITICURE (TM)
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Pharmaceutical forms |
Chewable/dispersible tablet
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Routes of administration |
Sublingual use
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Dosage and administration details |
12-SQ, QD
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Arm title
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Placebo | |||||||||||||||||||||
Arm description |
Placebo | |||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dispersible tablet
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Routes of administration |
Sublingual use
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Dosage and administration details |
No active ingredient, QD
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Baseline characteristics reporting groups
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Reporting group title |
Active
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Reporting group description |
SQ HDM-SLIT | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Active
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Reporting group description |
SQ HDM-SLIT | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo |
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End point title |
Delta IFN-B mRNA rel. to UBC/GADPH | ||||||||||||
End point description |
Delta IFN-B is calculated within groups from baseline to week-24 (follow-up)
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End point type |
Primary
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End point timeframe |
Baseline and Week-24
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Attachments |
Untitled (Filename: Eudract IFN.png) |
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Statistical analysis title |
Delta IFN-B mRNA expression rel to UBC/GADPH | ||||||||||||
Statistical analysis description |
Total RNA was extracted from HBECs using a RNeasy Plus Mini Kit (Qiagen) and 1 μg of
RNA was reverse transcribed to cDNA (High-Capacity cDNA Reverse Transcription Kit,
applied biosystems, Thermo Fisher Scientific). Amplification was performed by AriaMX realtime
PCR system (Agilent Technologies, Glostrup, Denmark) as previously described. Target
genes are listed in the Online Supplementary. The -ΔΔCt method was then applied for relative
quantification using UBC/GAPDH as housekeeping genes
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Comparison groups |
Active v Placebo
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.41 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Full study
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
RedCap | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Active
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Reporting group description |
SQ HDM-SLIT | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Jun 2020 |
Amendment v.2.2.
Deletion of exclusion criteria: Birch sensitisation
Change GINA 3-5 to 2-4
Add inclusion criteria Dose of ICS budesonide equivalent ≥400 μg
Change inclusion criteria: Moderate to severe rhinitis to HDM induced mild-severe allergic rhinitis for at least 1 year |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/36701676 |