Clinical Trial Results:
Training in intralymphatically injection technique. A realistic learning study
Summary
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EudraCT number |
2014-004031-40 |
Trial protocol |
DK |
Global end of trial date |
29 Nov 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Dec 2020
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First version publication date |
16 Dec 2020
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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 |
Version3.22.11.2014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
ILIT Læringsstudie, Department of Respiratory Diseases, Aarhus University Hospital, 0045 7846 2106 , hans.jurgen.hoffmann@ki.au.dk
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Scientific contact |
ILIT Læringsstudie, Department of Respiratory Diseases, Aarhus University Hospital, 0045 7846 2106 , hans.jurgen.hoffmann@ki.au.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 |
29 Nov 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Nov 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Nov 2020
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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 |
We would like to examine how the new treatment with intralymphatically injections can be learned by doctors with no previous experience in the treatment.
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Protection of trial subjects |
Followed Danish regulations
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Nov 2014
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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: 175
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Worldwide total number of subjects |
175
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EEA total number of subjects |
175
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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) |
175
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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 |
- | ||||||||||
Pre-assignment
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Screening details |
Allergic rhinoconjunctivits. | ||||||||||
Pre-assignment period milestones
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Number of subjects started |
175 | ||||||||||
Number of subjects completed |
175 | ||||||||||
Period 1
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Period 1 title |
Pre-ILIT grass pollen season
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Intervention | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000squ.
Intralymphatic administration
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Period 2
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Period 2 title |
Post-ILIT grass pollen season
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Intervention | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000squ.
Intralymphatic administration
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Period 3
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Period 3 title |
First injection
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Intervention | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000squ.
Intralymphatic administration
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Period 4
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Period 4 title |
Second injection
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Intervention | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000squ.
Intralymphatic administration
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Period 5
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Period 5 title |
Third Injection
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Intervention | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000squ.
Intralymphatic administration
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Baseline characteristics reporting groups
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Reporting group title |
Pre-ILIT grass pollen season
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
- | ||
Reporting group title |
Intervention
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Reporting group description |
- | ||
Reporting group title |
Intervention
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Reporting group description |
- | ||
Reporting group title |
Intervention
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Reporting group description |
- | ||
Reporting group title |
Intervention
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Reporting group description |
- |
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End point title |
Injection score | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
First, second and third injection.
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Statistical analysis title |
Injection score | ||||||||||||||||
Comparison groups |
Intervention v Intervention v Intervention
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Number of subjects included in analysis |
473
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||
P-value |
= 0.12 [1] | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Point estimate |
1
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||||||
upper limit |
1 | ||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
1
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Notes [1] - Anova p value 0.12. Parameter estimates not calculated and reported below are fictive numbers. |
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End point title |
cSMS | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pre-ILIT to post-ILIT
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Statistical analysis title |
pre-post cSMS | |||||||||||||||
Comparison groups |
Intervention v Intervention
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Number of subjects included in analysis |
314
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||
P-value |
< 0.0001 | |||||||||||||||
Method |
t-test, 2-sided | |||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||
Point estimate |
0.65
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
0.54 | |||||||||||||||
upper limit |
0.76 | |||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
0.67
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Adverse events information
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Timeframe for reporting adverse events |
All study period.
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Assessment type |
Systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
- | ||||||||||||||||||||
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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? No | |||
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/33099797 |