Condition category
Respiratory
Date applied
22/09/2011
Date assigned
10/10/2011
Last edited
12/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hay fever (seasonal allergic rhinitis) is a common allergic condition caused by pollen. Allergen immunotherapy (sometimes called desensitisation treatment) is a treatment that involves giving the patient increasing doses of grass pollen. It is recommended for patients when drug treatment does not bring satisfactory results. Allergen immunotherapy reduces both allergy symptoms and the quantity of drugs prescribed. It is usually given to a patient for three to five years. The treatment can be given by injection (subcutaneous immunotherapy), or by drops placed under the tongue (oral immunotherapy). Two different types of subcutaneous immunotherapy are most frequently used in hay fever patients, pre-seasonal and maintenance, but no studies have compared these two methods so far. The aim of this study is to compare the effects of three-year maintenance and pre-seasonal subcutaneous immunotherapy on patients with hay fever.

Who can participate?
Hay fever patients over five years of age from the Bialystok region (Poland)

What does the study involve?
A detailed history is collected from every participant and a physical examination is performed. Skin prick tests are performed with 11 common allergens, along with breathing tests. Participants are randomly allocated to either maintenance or pre-seasonal subcutaneous immunotherapy with a vaccine made from six grass pollens. In both groups, immunotherapy begins with a build-up phase, gradually reaching the maintenance dose of the vaccine in 7 to 14 day intervals. After reaching the maintenance dose, this dose is administered every two to four weeks in the pre-seasonal group and every four to six weeks in the maintenance group. Every year before the pollen season, patients from the pre-seasonal group are given a package containing 10 injections of the vaccine. Patients from the maintenance group , after reaching a well-tolerated dose, are given booster injections for a period of three years. These two groups are compared in terms of breathing changes caused by breathing in a grass-pollen mixture. This test is performed before starting subcutaneous immunotherapy and yearly thereafter, between November and January.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Medical University of Bialystok (Poland) (ref: 3-18503P)

When is the study starting and how long is it expected to run for?
October 2005 to December 2009

Who is funding the study?
Medical University of Bialystok (Poland)

Who is the main contact?
Prof. Zenon Siergiejko
siergiejko@csk.pl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zenon Siergiejko

ORCID ID

Contact details

Respiratory System Diagnostic and Bronchoscopy Department
Medical University of Bialystok
ul. J. Waszyngtona 17
Bialystok
15-274
Poland
-
siergiejko@csk.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3-18503P

Study information

Scientific title

Maintenance versus pre-seasonal allergoid immunotherapy in seasonal allergic rhinitis: a randomized trial

Acronym

Study hypothesis

Pre-seasonal and maintenance protocols of subcutaneous immunotherapy differ in regards to the type and severity of bronchial response during bronchial challenge in seasonal allergic rhinitis subjects.

Ethics approval

Medical University of Bialystok (Poland), 30/11/2006, ref: R-I-003/299/2006

Study design

Randomized open trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Seasonal allergic rhinitis

Intervention

In both arms, immunotherapy will begin with a build-up phase, i.e. gradually reaching the maintenance dose (increasing volumes of 0.1 ml, 0.2 ml, 0.4 ml and 0.8 ml will be administered subcutaneously in 7 to 14 day intervals from vial A containing 1000 TU/ml of allergoid, followed by 0.15 ml, 0.30 ml and 0.6 ml from vial B containing 10000 TU/ml of allergoid). After reaching the maintenance dose, usually equal to 6000 TU of allergoid, this dose will be administered every two to four weeks or every four to six weeks in the pre-seasonal and maintenance arms, respectively. Every year before the pollen season, patients from the pre-seasonal arm will be given one package (one vial of A and B), usually divided into 10 injections, corresponding to 30000 TU yearly dose of allergoid. Patients from the maintenance arm, after reaching a well-tolerated dose not exceeding 0.6 ml, will be given booster injections for a period of three years.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

1. Bronchial response distributions after bronchial allergen challenge (BAC)
2. Provocative concentration causing a 20% fall in forced expiratory volume in one second (PC20FEV1)
3. Maximal decrease in forced expiratory volume in one second (FEV1) determined during late asthmatic response

Secondary outcome measures

Nitric oxide concentration in exhaled air (FeNO) determined prior to and after bronchial allergen challenge (BAC)

Overall trial start date

01/10/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. History of seasonal allergic rhinitis
2. Confirmed sensitivity to grass pollen
3. More than five years of age
4. Ability to proper performance of spirometry

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

60

Participant exclusion criteria

Current or past active and passive tobacco-smoking

Recruitment start date

01/10/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Poland

Trial participating centre

Medical University of Bialystok
Bialystok
15-274
Poland

Sponsor information

Organisation

Medical University of Bialystok (Poland)

Sponsor details

ul. Jana Kiliñskiego 1
Bialystok
15-089
Poland
-
dzialnau@umb.edu.pl

Sponsor type

University/education

Website

http://ed.umb.edu.pl/

Funders

Funder type

University/education

Funder name

Uniwersytet Medyczny w Bialymstoku

Alternative name(s)

Medical University of Bialystok

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Poland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22280547

Publication citations

  1. Results

    Świebocka EM, Siergiejko P, Rapiejko P, Siergiejko Z, Allergenic immunotherapy and seasonal changes in nitric oxide concentration in exhaled air in seasonal rhinitis patients., J Aerosol Med Pulm Drug Deliv, 2012, 25, 3, 154-158, doi: 10.1089/jamp.2011.0917.

Additional files

Editorial Notes

12/10/2016: Plain English summary added.