Maintenance versus pre-seasonal allergoid immunotherapy in seasonal allergic rhinitis
| ISRCTN | ISRCTN86562422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86562422 |
| Secondary identifying numbers | 3-18503P |
- Submission date
- 22/09/2011
- Registration date
- 10/10/2011
- Last edited
- 12/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Respiratory System Diagnostic and Bronchoscopy Department
Medical University of Bialystok
ul. J. Waszyngtona 17
Bialystok
15-274
Poland
| siergiejko@csk.pl |
Study information
| Study design | Randomized open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Maintenance versus pre-seasonal allergoid immunotherapy in seasonal allergic rhinitis: a randomized trial |
| Study objectives | 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(s) | Medical University of Bialystok (Poland), 30/11/2006, ref: R-I-003/299/2006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | Current or past active and passive tobacco-smoking |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Poland
Study participating centre
15-274
Poland
Sponsor information
University/education
ul. Jana Kiliñskiego 1
Bialystok
15-089
Poland
| dzialnau@umb.edu.pl | |
| Website | http://ed.umb.edu.pl/ |
"ROR" |
https://ror.org/00y4ya841 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Medical University of Bialystok
- Location
- Poland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
Editorial Notes
12/10/2016: Plain English summary added.
