Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000445774
Ethics application status
Approved
Date submitted
16/04/2013
Date registered
18/04/2013
Date last updated
18/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Molecular evidence underlying specific immunotherapy in patients with allergic rhinitis
Scientific title
Th17 response to specific immunotherapy in house dust mite-induced allergic rhinitis patients
Secondary ID [1] 282343 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis
 288892 0
Condition category
Condition code
Inflammatory and Immune System 289236 289236 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects were received subcutaneous immunotherapy (SCIT) for 2 years. SIT was performed with a standardized mite depot-allergen extract (50% Der P and 50% Der f) according to the recommendations of the manufacturer Allergopharma Joachim Ganzer KG (Reinbek, Germany). The build-up phase (25 weeks) began at 5TU/ml of the final concentration and increased to 50TU/ml, 500TU/ml, and 5000TU/ml at 5-week intervals as tolerated. Maintenance immunotherapy was administrated with the 5000TU/ml concentration bi-weekly for 54 weeks and then tri-weekly for 27 weeks.
Intervention code [1] 286960 0
Treatment: Drugs
Comparator / control treatment
Healthy volunteers without any allergy history were selected as a control group. The subjects in control group were not received any treatment.
Control group
Active

Outcomes
Primary outcome [1] 289354 0
Clinical symptoms assessed by visual analogue scale (VAS). The subjects were instructed that “Score 0” meant “overall symptoms not all bothersome” and that “Score 10” meant “overall symptoms extremely bothersome”.
Timepoint [1] 289354 0
2 years after administration
Secondary outcome [1] 302298 0
Th17 response was inhibited by immunotherapy in patients with allergic rhinitis, by assessing the expression levels of Th17 associated genes.
Timepoint [1] 302298 0
2 years after adminstration

Eligibility
Key inclusion criteria
Patients were (1) age from 20 to 45 years old; (2) having persistent AR symptoms during the past two consecutive years; (3) allergic sensitization to Dermatophagoides pteronyssinus, (Der p) & Dermatophagoides farina (Der f)) confirmed by both skin prick test (SPT) and ImmunoCap (Registered Trademark) (Phadia, Uppsala, Sweden); (4) no previous treatment of SIT; and (5) negative SPT results to other common inhalant allergens (e.g., common pollens, cockroach, fungi, and animal dander). Healthy subjects without any allergy history and allergic symptoms were selected as a control group.
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All recruited subjects (both allergic rhintis patients and healthy controls) did not have an infection, asthma, autoimmune diseases, or other upper airway diseases such as septal deviation, nasal polyps, or sinusitis before enrolment. Furthermore, all participants had not received any form of steroids or SIT at least six months before the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2008
Actual
10/09/2008
Date of last participant enrolment
Anticipated
Actual
28/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5019 0
China
State/province [1] 5019 0

Funding & Sponsors
Funding source category [1] 287100 0
Government body
Name [1] 287100 0
Science and Technology Planning Project of Guangdong Province, China (No. 99M04901G)
Country [1] 287100 0
China
Primary sponsor type
Individual
Name
Li Tian Ying
Address
Department of Otorhinolaryngology,
The First Affiliated Hospital of Sun Yat-Sen University,
Zhong Shan second St. 58
Guangzhou,

Postcode: 510010
Country
China
Secondary sponsor category [1] 285876 0
Hospital
Name [1] 285876 0
The First Affiliated Hospital of Sun Yat-Sen University
Address [1] 285876 0
Zhong Shan second St. 58
Guangzhou,
Postcode: 510010
Country [1] 285876 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289114 0
The First Affiliated Hospital of Sun Yat-Sen University, Ethical Comittee
Ethics committee address [1] 289114 0
The First Affiliated Hospital of Sun Yat-Sen University,
Zhong Shan second St. 58
Guangzhou,
Postcode: 510010
Ethics committee country [1] 289114 0
China
Date submitted for ethics approval [1] 289114 0
Approval date [1] 289114 0
Ethics approval number [1] 289114 0

Summary
Brief summary
Allergic rhinitis (AR) patients who were monosensitized to house dust mite were collected before the initiation of specific immunotherapy (SIT) (SIT-untreated) and after the end of 2-year SIT (SIT-treated) treatment. The impact of specific immunotherapy on Th17 response and Th1/Th2/Treg changes in AR patients was investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39318 0
Prof LI Tian Ying
Address 39318 0
Department of Otorhinolaryngology,
The First Affiliated Hospital of Sun Yat-Sen University,
Zhong Shan second St. 58
Guangzhou,
Postcode: 510010
Country 39318 0
China
Phone 39318 0
86-20-87332200-8483
Fax 39318 0
Email 39318 0
[email protected]
Contact person for public queries
Name 39319 0
Dr LI Chun Wei
Address 39319 0
Department of Otolaryngology,
National University of Singapore,
10 Medical Drive, #03-17
Postcode: 117597
Country 39319 0
Singapore
Phone 39319 0
65-68745184
Fax 39319 0
Email 39319 0
[email protected]
Contact person for scientific queries
Name 39320 0
Dr LI Chun Wei
Address 39320 0
Department of Otolaryngology,
National University of Singapore,
10 Medical Drive, #03-17
Postcode: 117597
Country 39320 0
Singapore
Phone 39320 0
65-68745184
Fax 39320 0
Email 39320 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
EmbaseIn vivo and in vitro studies of Th17 response to specific immunotherapy in house dust mite-induced allergic rhinitis patients.2014https://dx.doi.org/10.1371/journal.pone.0091950
N.B. These documents automatically identified may not have been verified by the study sponsor.