Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000543987
Ethics application status
Approved
Date submitted
23/05/2011
Date registered
30/05/2011
Date last updated
6/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized, double-blind, placebo-controlled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients
Scientific title
Randomized, double-blind, placebo-controlled clinical trial of sublingual immunotherapy in natural rubber latex (NRL) allergic patients
Secondary ID [1] 262241 0
NIL
Universal Trial Number (UTN)
U1111-1121-6078
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Latex allergy 267934 0
Condition category
Condition code
Inflammatory and Immune System 268080 268080 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sublingual immunotherapy (SLIT) to latex (SLIT latex, ALK-Abello, Madrid, Spain). The SLIT is oral fluid.
The treatment was administered once a day: two drops of SLIT each day. The study was performed in two phases: the first one, double-blind, placebo-controlled during one year; and the second one, also for one year, opened, where every patient received active treatment.
Intervention code [1] 266631 0
Treatment: Other
Comparator / control treatment
Placebo.
The placebo was made of the same dilution liquid (water) used in the active treatment. The active treatment had no taste, and had clear appearance, so no masking was required.
Control group
Placebo

Outcomes
Primary outcome [1] 266818 0
Size of wheal in skin prick test measured by parallel lines assay
Timepoint [1] 266818 0
1, 6, 12, 18 and 24 months
Secondary outcome [1] 276443 0
Conjunctival challenge test.
The difference in the concentration of latex extract needed to obtain 5 points of symptoms in the conjunctival challenge test was compared between placebo and active groups after one year of active treatment and intragroup after one and two years of treatment.
Timepoint [1] 276443 0
0, 12 and 24 months
Secondary outcome [2] 276444 0
Glove use test.
The difference in the time using the latex glove needed to obtain 5 points of symptoms in the glove used test was compared between placebo and active groups after one year of active treatment and intragroups after one and two years of treatment.
Timepoint [2] 276444 0
0, 12 and 24 months
Secondary outcome [3] 276445 0
Basophil Activation Test.
Timepoint [3] 276445 0
0, 12 and 24 months
Secondary outcome [4] 276446 0
Specific IgE determination.
Specific IgE to NRL was measured using commercial uniCAP (Phadia, Sweden) to NRL (k81), and to recombinant main allergenic components of latex (Hev b 1, hev b 3, hev b 5, Hev b 6, and Hev b 8). The results were compared between placebo and active groups after one year of active treatment and intragroups after one and two years of treatment.
Timepoint [4] 276446 0
0, 12 and 24 months

Eligibility
Key inclusion criteria
Inclusion criteria comprised a clinical history of natural rubber latex allergy (documenting the usual symptoms of urticaria, angioedema, rhinitis, conjunctivitis, asthma or anaphylaxis) or a positive response to the gloves use test and/or conjunctival test plus positive prick test to NRL (wheal greater than or equal to 3x3 mm).
Minimum age
24 Years
Maximum age
57 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria consisted of the usual contraindications for the use of immunotherapy and the presence of severe systemic or psychiatric diseases, chronic urticaria or dermographism.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomization table in 4-patient groups was performed. Each patient was assigned to a correlative number. The investigator who included the patients was unaware to which group the subject was allocated.
Allocation was made assigning a correlative number to each patient. Treatments, active and placebo were bought to the laboratory (ALK-Abello). The laboratory created a randomization table, in 4 patient-groups (each 4 correlative patients, 2 were placebo and 2 active) and labelled the treatments with one number. The external appearence of placebo or active treatments were identical.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The manufacturing laboratory generated by means of a computer programme, a random allocation table by 4-item groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 3601 0
Spain
State/province [1] 3601 0
Alava

Funding & Sponsors
Funding source category [1] 267122 0
Government body
Name [1] 267122 0
FIS (PI04/2301)
Country [1] 267122 0
Spain
Funding source category [2] 267123 0
Charities/Societies/Foundations
Name [2] 267123 0
Foundation Jesus Gangoiti Barrera 2004
Country [2] 267123 0
Spain
Funding source category [3] 267124 0
Charities/Societies/Foundations
Name [3] 267124 0
Foundation SEAIC (Spanish Society of Allergy and Clinical Immunology)
Country [3] 267124 0
Spain
Funding source category [4] 267125 0
Charities/Societies/Foundations
Name [4] 267125 0
Research Foundation of the Santiago Apostol Hospital
Country [4] 267125 0
Spain
Primary sponsor type
Hospital
Name
Allergy Service. Hospital Santiago Apostol
Address
C/ Olaguibel, no29 01004 Vitoria - Gasteiz
Country
Spain
Secondary sponsor category [1] 264203 0
Hospital
Name [1] 264203 0
Clinical Assays Unit. Txagorritxu Hospital
Address [1] 264203 0
Hospital Txagorritxu
Jose Atxotegui, s/n.
01009 Vitoria
Country [1] 264203 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267108 0
Ethics Committee of the Santiago Apostol Hospital
Ethics committee address [1] 267108 0
Ethics committee country [1] 267108 0
Spain
Date submitted for ethics approval [1] 267108 0
Approval date [1] 267108 0
16/07/2003
Ethics approval number [1] 267108 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32650 0
Address 32650 0
Country 32650 0
Phone 32650 0
Fax 32650 0
Email 32650 0
Contact person for public queries
Name 15897 0
Gabriel Gastaminza
Address 15897 0
Department of Allergology and Clinical Immunology
Clinica Universidad de Navarra
Pío XII 36
31008 Pamplona
Country 15897 0
Spain
Phone 15897 0
0034948255400
Fax 15897 0
0034948296500
Email 15897 0
[email protected]
Contact person for scientific queries
Name 6825 0
Gabriel Gastaminza
Address 6825 0
Department of Allergology and Clinical Immunology
Clinica Universidad de Navarra
Pío XII 36
31008 Pamplona
Country 6825 0
Spain
Phone 6825 0
0034948255400
Fax 6825 0
0034948296500
Email 6825 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRandomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients2011https://doi.org/10.1186/1745-6215-12-191
N.B. These documents automatically identified may not have been verified by the study sponsor.