Clinical Trial Results:
A Randomised, Double-blind, Single-centre, Controlled Trial of Low Dose Intradermal Allergen Immunotherapy in Adults with Seasonal Allergic Rhinitis
Summary
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EudraCT number |
2012-002193-31 |
Trial protocol |
GB |
Global end of trial date |
27 Aug 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Oct 2018
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First version publication date |
13 Oct 2018
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Other versions |
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Summary report(s) |
STUDY 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 |
PollenLITE
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Additional study identifiers
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ISRCTN number |
ISRCTN78413121 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
The Strand, London, United Kingdom, WC2R 2LS
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Public contact |
Dr Stephen Till, King's College London, +44 02071880599, stephen.till@kcl.ac.uk
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Scientific contact |
Dr Stephen Till, King's College London, +44 02071880599, stephen.till@kcl.ac.uk
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Sponsor organisation name |
Guy's and St Thomas' NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE19RT
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Public contact |
Dr Stephen Till, Guy's and St Thomas' NHS Foundation Trust, +44 02071880599, stephen.till@kcl.ac.uk
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Scientific contact |
Dr Stephen Till, Guy's and St Thomas' NHS Foundation Trust, +44 02071880599, stephen.till@kcl.ac.uk
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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 |
27 Aug 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Aug 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Aug 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 determine if pre-seasonal low dose intradermal grass pollen allergen immunotherapy (either 7 or 8 two-weekly injections of 10 Biological Units (33.333 SQ-U)) reduces symptoms and requirements for anti-allergic drugs in seasonal allergic rhinitis during the 2013 grass pollen season compared to the control intervention (histamine only).
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Protection of trial subjects |
Paricipants were followed-up at 4 months and randomised for follow-up at either 7, 10 or 13 months following final vaccine for open label intradermal skin tests with grass pollen (10 BU)
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Background therapy |
None | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Oct 2012
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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 |
United Kingdom: 93
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Worldwide total number of subjects |
93
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EEA total number of subjects |
93
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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) |
93
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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 |
Ninety-three participants allergic to grass pollen were enrolled and randomised to receive the first intradermal injection of grass pollen or histamine control between February 18 and March 1 of 2013 | |||||||||||||||
Pre-assignment
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Screening details |
Inclusion Criteria 1) Adults aged 18 to 65 years. 2) A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July. 3) A clinical history of moderate-severe persistent rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep. | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
93 | |||||||||||||||
Number of subjects completed |
93 | |||||||||||||||
Period 1
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Period 1 title |
Whole Group (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 | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ACTIVE | |||||||||||||||
Arm description |
The active drug will be 1 O Biological Units (BU) (33.333 SQ-U) of Ph/eum pretense soluble grass pollen extract (Aquagen SQ Timothy, ALK Abello) contained in a 20 microlitre volume (i.e. 500 BU/ml (1666.666 SQ-U/ml)). | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Aquagen SQ Timothy
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
A series of 7 intradermal active or control injections will be administered 2-weekly into the
forearm between before the 2013 grass pollen season. 1 O Biological Units at each injection
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Arm title
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CONTROL GROUP | |||||||||||||||
Arm description |
Control will be histamine only, administered at a concentration of 100 mcg/ml (histamine dose validated by Sherer et al., Clin Exp Allergy. 2007;37:39-46). To help preserve blinding, histamine concentrations·will be reduced to 30 mcg/ml for the 3rd and 4th injections, and 10 mcg/ml for 5, 6 and ?1h injections. To match the grass pollen extract dilution and preserve blinding, histamine will also be aliquoted into study vials at 60-times final working strength in 0.15 ml volumes, for further dilution with 8.85 ml of clinical grade 0.9% normal saline immediately prior to injection. | |||||||||||||||
Arm type |
CONTROL | |||||||||||||||
Investigational medicinal product name |
HISTAMINE
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
A series of 7 intradermal active or control injections will be administered 2-weekly into the
forearm between before the 2013 grass pollen season. The first injection will be administered
between 18th February and 1st March 2013. We will aim to administer the 7th injection between
13th May and 24th May 2013. The injection site will again be alternated between left and right
arms at each visit. lntradermal injections will be administered in a 20 microlitre volume using a
29 gauge insulin syringe (Becton Dickinson Micro-FineTM).
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Baseline characteristics reporting groups
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Reporting group title |
Whole Group
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ACTIVE
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Reporting group description |
The active drug will be 1 O Biological Units (BU) (33.333 SQ-U) of Ph/eum pretense soluble grass pollen extract (Aquagen SQ Timothy, ALK Abello) contained in a 20 microlitre volume (i.e. 500 BU/ml (1666.666 SQ-U/ml)). | ||
Reporting group title |
CONTROL GROUP
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Reporting group description |
Control will be histamine only, administered at a concentration of 100 mcg/ml (histamine dose validated by Sherer et al., Clin Exp Allergy. 2007;37:39-46). To help preserve blinding, histamine concentrations·will be reduced to 30 mcg/ml for the 3rd and 4th injections, and 10 mcg/ml for 5, 6 and ?1h injections. To match the grass pollen extract dilution and preserve blinding, histamine will also be aliquoted into study vials at 60-times final working strength in 0.15 ml volumes, for further dilution with 8.85 ml of clinical grade 0.9% normal saline immediately prior to injection. |
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End point title |
A combined symptom and medication score during the grass pollen season period of mid May-August 2013. [1] | ||||||||||||
End point description |
daily combined symptom and medication scores according to treatment group over the 2013 grass pollen season
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End point type |
Primary
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End point timeframe |
During grass pollen season between mid May-August 2013.
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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: See attached study report for full analysis |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Throughout whole trial
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
ACTIVE
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Reporting group description |
The active drug will be 1 O Biological Units (BU) (33.333 SQ-U) of Ph/eum pretense soluble grass pollen extract (Aquagen SQ Timothy, ALK Abello) contained in a 20 microlitre volume (i.e. 500 BU/ml (1666.666 SQ-U/ml)). | |||||||||||||||||||||||||||||||||
Reporting group title |
CONTROL GROUP
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Reporting group description |
Control will be histamine only, administered at a concentration of 100 mcg/ml (histamine dose validated by Sherer et al., Clin Exp Allergy. 2007;37:39-46). To help preserve blinding, histamine concentrations·will be reduced to 30 mcg/ml for the 3rd and 4th injections, and 10 mcg/ml for 5, 6 and ?1h injections. To match the grass pollen extract dilution and preserve blinding, histamine will also be aliquoted into study vials at 60-times final working strength in 0.15 ml volumes, for further dilution with 8.85 ml of clinical grade 0.9% normal saline immediately prior to injection. | |||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||
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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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11 Jul 2013 |
Four additional secondary endpoints have been added and the statistical analysis section has been re-worded for clarification. The changes are being made following the finalisation of the statistical analysis plan by the statistician and before the collection of primary outcome data is commenced. |
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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/27977090 |