Clinical Trial Results:
Biological standardization of Alternaria alternata allergen extract to determine the biological activity in histamine equivalent units (HEP).
Summary
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EudraCT number |
2013-001308-13 |
Trial protocol |
ES |
Global end of trial date |
26 Nov 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
15 Dec 2022
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First version publication date |
15 May 2022
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Other versions |
v1 |
Version creation reason |
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Summary report(s) |
Synopsis Final Report |
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 |
301-PR-PRI-198
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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 |
Laboratorios LETI S.L.U.
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Sponsor organisation address |
c/ SOL, TRES CANTOS, MADRID, Spain, 28760
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Public contact |
Departamento Médico, Laboratorios LETI S.L.U, +34 917711790, clinicalresearch@leti.com
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Scientific contact |
Departamento Médico, Laboratorios LETI S.L.U, +34 917711790, clinicalresearch@leti.com
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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 |
24 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Nov 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Nov 2014
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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 |
The primary objective is to assess the concentration of Alternaria Alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
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Protection of trial subjects |
According to ICH-GCP, patients had to give their consent to participate in the clinical trial, only after
having been fully informed by the investigator of the nature, significance and implications thereof
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Feb 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Spain: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
30
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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 |
Clinical history of respiratory allergy (rhinitis and / or rhinoconjunctivitis and / or asthma) against Alternaria alternata. | ||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Experimental | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Alternaria alternata allergen extract
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
10, 1, 0.1, 0.01 mg/ml
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Investigational medicinal product name |
histamine dyhidrochloride solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
10mg/ml
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Investigational medicinal product name |
Saline solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Not applicable
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
- |
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End point title |
Efficacy [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
The total duration of the study for a patient was approximately 30 minutes plus at least 30 minutes,
under observation in the medical rooms, after the application of the Titrated Skin Prick test.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical results were not relevant for publish |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the clinical trial, adverse events could be spontaneously reported or elicited during open- ended
questioning, examination, or evaluation of the patien
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
5
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The stusy was cancelled and no statistical data weas performed |
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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 |