Seasonal Allergic RhinitisPhase 4NCT01555736
Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy
A Phase 4 study testing grass (80%) and rye (20%) pollens allergoids in people with Seasonal Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- grass (80%) and rye (20%) pollens allergoids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2003to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July);
- Symptoms of allergic rhinoconjunctivitis requiring medication during the last season
- Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter > 5mm;
- For female patients effective contraception and negative pregnancy test results were necessary.
Who cannot join
- Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years
- FEV1 < 80% of predicted
- Uncontrolled bronchial asthma according to GINA
- Non-allergic rhinoconjunctivitis
- Severe acute or chronic diseases, severe inflammatory diseases
- Autoimmune diseases, immunosuppression, neoplastic diseases
Show all 12Show fewer
- Severe psychiatric and psychological disorders including alcohol or drug abuse
- Contraindication for application of adrenaline;
- Treatment with beta-blockers
- Pregnancy or lactation period
- Females patients seeking to become pregnant
- Low compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-blind Clinical Trial for Evaluation of Efficacy and Safety of Perennial in Comparison to Preseasonal Grass/Rye Pollen Immunotherapy in Patients Suffering From Seasonal Allergic Rhinitis
Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. According to the latest studies immunotherapy not only reduces symptoms' severity but also may modify the course of allergic disease by reducing the risk of new sensitisations and development of more advanced stages of the disease.It has been hypothesized basing on clinical observation that perennial immunotherapy is more effective and safer in comparison to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- grass (80%) and rye (20%) pollens allergoids
- Keywords
- allergic rhinitis, perennial immunotherapy, preseasonal immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grass (80%) and rye (20%) pollens allergoidsDrug
Also called Allergovit
comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| preseasonal immunotherapy scheme | Active comparator | Not described Receives: Drug: grass (80%) and rye (20%) pollens allergoids |
| perennial immunotherapy scheme | Active comparator | Not described Receives: Drug: grass (80%) and rye (20%) pollens allergoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
Measured: up to 3 months
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
Measured: up to 3 months
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
Measured: up to 3 months
Secondary outcomes (8)
frequency of adverse reactions during immunotherapy
Measured: up to 3 years of immunotherapy
type of adverse reactions
Measured: up to 3 years of immunotherapy
the differences from baseline in mean daily rhinoconjunctivitis symptoms score
Measured: up to 3 months/4 years
the differences between study groups in mean daily rhinoconjunctivitis symptoms score
Measured: up to 3 months/4 years
the differences from baseline in combined symptom medication score
Measured: up to 3 months/4 years
the differences from baseline a in serum level of sIgG4
Measured: the peak of each pollen season (June) during 4 years of study
the differences between study groups in combined symptom medication score
Measured: up to 3 months/4 years
the differences between study groups in serum level of sIgG4
Measured: up to 3 months/4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJan 2003
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Allergopharma GmbH & Co. KG
- Responsible party
- Principal investigator, Piotr Kuna, MD, PhD, Medical University of Lodz
- Investigators
- Piotr Kuna, MD, PhD, Principal investigator, Department of Internal Diseases, Asthma and allergy, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555736
- Sponsor's protocol ID
- Ne0103AV
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tworek D, Bochenska-Marciniak M, Kuprys-Lipinska I, Kupczyk M, Kuna P. Perennial is more effective than preseasonal subcutaneous immunotherapy in the treatment of seasonal allergic rhinoconjunctivitis. Am J Rhinol Allergy. 2013 Jul-Aug;27(4):304-8. doi: 10.2500/ajra.2013.27.3935. Epub 2013 Apr 29.
PubMed 23636036
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Clinical Trial for Evaluation of Efficacy and Safety of Perennial in Comparison to Preseasonal Grass/Rye Pollen Immunotherapy in Patients Suffering From Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01555736
- Acronym / sponsor ID
- Ne0103AV
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- allergic rhinitis, perennial immunotherapy, preseasonal immunotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Allergopharma GmbH & Co. KG
- Study start
- Jan 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. According to the latest studies immunotherapy not only reduces symptoms' severity but also may modify the course of allergic disease by reducing the risk of new sensitisations and development of more advanced stages of the disease.It has been hypothesized basing on clinical observation that perennial immunotherapy is more effective and safer in comparison to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preseasonal immunotherapy scheme | Active comparator | Drug: grass (80%) and rye (20%) pollens allergoids |
| perennial immunotherapy scheme | Active comparator | Drug: grass (80%) and rye (20%) pollens allergoids |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July);
- Symptoms of allergic rhinoconjunctivitis requiring medication during the last season
- Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter > 5mm;
- For female patients effective contraception and negative pregnancy test results were necessary.
Key exclusion criteria (12 listed)
- Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years
- FEV1 < 80% of predicted
- Uncontrolled bronchial asthma according to GINA
- Non-allergic rhinoconjunctivitis
- Severe acute or chronic diseases, severe inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| grass (80%) and rye (20%) pollens allergoidsAlso: Allergovitcomparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy. | Drug | perennial immunotherapy scheme, preseasonal immunotherapy scheme |
Primary outcome
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy
Time frame: up to 3 months
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy
Time frame: up to 3 months
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy
Time frame: up to 3 months
combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season
8 secondary outcomes
frequency of adverse reactions during immunotherapy
Time frame: up to 3 years of immunotherapy
type of adverse reactions
Time frame: up to 3 years of immunotherapy
the differences from baseline in mean daily rhinoconjunctivitis symptoms score
Time frame: up to 3 months/4 years
the differences between study groups in mean daily rhinoconjunctivitis symptoms score
Time frame: up to 3 months/4 years
the differences from baseline in combined symptom medication score
Time frame: up to 3 months/4 years
the differences from baseline a in serum level of sIgG4
Time frame: the peak of each pollen season (June) during 4 years of study
the differences between study groups in combined symptom medication score
Time frame: up to 3 months/4 years
the differences between study groups in serum level of sIgG4
Time frame: up to 3 months/4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Derived from this study: PubMed 23636036Tworek D, Bochenska-Marciniak M, Kuprys-Lipinska I, Kupczyk M, Kuna P. Perennial is more effective than preseasonal subcutaneous immunotherapy in the treatment of seasonal allergic rhinoconjunctivitis. Am J Rhinol Allergy. 2013 Jul-Aug;27(4):304-8. doi: 10.2500/ajra.2013.27.3935. Epub 2013 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Kuna, MD, PhD principal investigator
Department of Internal Diseases, Asthma and allergy, Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing grass (80%) and rye (20%) pollens allergoids in people with Seasonal Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01555736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.