Allergic RhinitisNCT02579720
Revaccination With Pollinex® Quattro
An observational study of Allergic Rhinitis, run by Prof. Dr. Ralph Mösges.
Trial summary
The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex® Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Oct 2015
- Phase
- Observational
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.
Who may be able to join
- Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.
- A previous specific immunotherapy finished at least five years ago had to be successful.
Who cannot join
- Contraindications according to the patient information leaflet
About this study
Official title: Non-interventional Study A Multicentre Observational Study for Revaccination With Pollinex® Quattro in Patients With a Recurrent Grass Pollen Allergy
The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex® Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.
Read the detailed description
The increasing prevalence of allergies represents a major problem for the health care system. Approximately 500 million people are suffering worldwide from allergic rhinitis (AR). Allergic rhinitis is a Type 1 hypersensitive disorder, initiated by IgE antibodies. Whereas seasonal allergic rhinitis (SAR) is caused by different allergens found outdoors such as grass, tree and weed pollen, perennial allergic rhinitis (PAR) is caused by allergens that are mainly found indoors such as dust mites, mould or animal hair.
Specific immunotherapy (SIT) presently constitutes the only causal therapy available and is common practice. SIT is indicated in cases of IgE-mediated allergic diseases and includes two forms of treatment options: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Both therapies aim to train the immune system not react to supposed pathological allergens, but instead to develop tolerance to them.
Even though allergy vaccinations have been applied for a century, the commonly used SCIT requires up to 90 injections over three to five years. Pollinex® Quattro is currently the only ultra-short term medicinal product which requires only four preseasonal injections. The immunological effect associated with Pollinex® Quattro shows an increase of allergen-specific IgG antibodies and a decrease of allergen-specific IgE antibodies as well as a shift from a Th2 to a more Th1 type-immune reaction. Previous studies on the therapeutic efficacy of Pollinex® Quattro have come to a positive conclusion in regards to tolerability and decrease of allergic symptoms. As an ultra-short course SCIT, Pollinex® Quattro might decrease the number of noncompliance and withdrawal for revaccination in patients that have already undergone an intensive immunisation therapy.
In this non-interventional study, patients who were treated with Pollinex® Quattro and patients who decided to use anti-allergic drugs for the treatment of their grass pollen allergy were compared due to their allergic symptoms in the grass pollen season from May to July. For this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of concomitant medication were documented in a dia
- Conditions
- Allergic Rhinitis
- Keywords
- Recurrent Grass Pollen Allergy, Pollinex® Quattro
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pollinex® Quattro Patients | Patients treated with Pollinex® Quattro | |
| Group 2: Control Patients | Patients who decided to use only anti-allergic drugs during the grass pollen season |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the efficacy of Pollinex® Quattro based on the Combined Symptom and Medication Score (CSMS) (Pfaar et al., 2014).
The CSMS consists of the six individual rhinoconjunctivitis scores for sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes, the asthma scores for cough, breathlessness, wheeze and tightness in the chest as well as the score for the use of concomitant medication (oral antihistamines, nasal corticosteroids, oral corticosteroids, asthma inhalation spray). The symptoms and the use of drugs were documented in a diary: The symptom score was:
0=none, 1=mild, 2=moderate, 3=severe. Evaluation will be done for the peak of the grass pollen season, defined by those 30 consecutive days per center with the highest local grass pollen counts (according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) measured in the nearest pollen count station in that region.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Ralph Mösges
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Sponsor-investigator, Prof. Dr. Ralph Mösges, University Hospital of Cologne
- Investigators
- Matthias Kramer, Prof. Dr., Study director, Bencard Allergie GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579720
- Sponsor's protocol ID
- BC Grass Booster 01 2014
- Status last verified
- Dec 2023
- First submitted
- 16 Oct 2015
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rosewich M, Lee D, Zielen S. Pollinex Quattro: an innovative four injections immunotherapy in allergic rhinitis. Hum Vaccin Immunother. 2013 Jul;9(7):1523-31. doi: 10.4161/hv.24631. Epub 2013 Apr 12.
PubMed 23584250Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.
PubMed 24761804
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study A Multicentre Observational Study for Revaccination With Pollinex® Quattro in Patients With a Recurrent Grass Pollen Allergy
- ClinicalTrials.gov ID
- NCT02579720
- Acronym / sponsor ID
- BC Grass Booster 01 2014
- Conditions
- Allergic Rhinitis
- Keywords
- Recurrent Grass Pollen Allergy, Pollinex® Quattro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Prof. Dr. Ralph MösgesUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Oct 2015 (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.
The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex® Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.
Detailed description
The increasing prevalence of allergies represents a major problem for the health care system. Approximately 500 million people are suffering worldwide from allergic rhinitis (AR). Allergic rhinitis is a Type 1 hypersensitive disorder, initiated by IgE antibodies. Whereas seasonal allergic rhinitis (SAR) is caused by different allergens found outdoors such as grass, tree and weed pollen, perennial allergic rhinitis (PAR) is caused by allergens that are mainly found indoors such as dust mites, mould or animal hair.
Specific immunotherapy (SIT) presently constitutes the only causal therapy available and is common practice. SIT is indicated in cases of IgE-mediated allergic diseases and includes two forms of treatment options: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Both therapies aim to train the immune system not react to supposed pathological allergens, but instead to develop tolerance to them.
Even though allergy vaccinations have been applied for a century, the commonly used SCIT requires up to 90 injections over three to five years. Pollinex® Quattro is currently the only ultra-short term medicinal product which requires only four preseasonal injections. The immunological effect associated with Pollinex® Quattro shows an increase of allergen-specific IgG antibodies and a decrease of allergen-specific IgE antibodies as well as a shift from a Th2 to a more Th1 type-immune reaction. Previous studies on the therapeutic efficacy of Pollinex® Quattro have come to a positive conclusion in regards to tolerability and decrease of allergic symptoms. As an ultra-short course SCIT, Pollinex® Quattro might decrease the number of noncompliance and withdrawal for revaccination in patients that have already undergone an intensive immunisation therapy.
In this non-interventional study, patients who were treated with Pollinex® Quattro and patients who decided to use anti-allergic drugs for the treatment of their grass pollen allergy were compared due to their allergic symptoms in the grass pollen season from May to July. For this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of concomitant medication were documented in a dia
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pollinex® Quattro Patients | – | –Patients treated with Pollinex® Quattro |
| Group 2: Control Patients | – | –Patients who decided to use only anti-allergic drugs during the grass pollen season |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.
Key inclusion criteria (2 listed)
- Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.
- A previous specific immunotherapy finished at least five years ago had to be successful.
Key exclusion criteria (1 listed)
- Contraindications according to the patient information leaflet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the efficacy of Pollinex® Quattro based on the Combined Symptom and Medication Score (CSMS) (Pfaar et al., 2014).
Time frame: 3 months
The CSMS consists of the six individual rhinoconjunctivitis scores for sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes, the asthma scores for cough, breathlessness, wheeze and tightness in the chest as well as the score for the use of concomitant medication (oral antihistamines, nasal corticosteroids, oral corticosteroids, asthma inhalation spray). The symptoms and the use of drugs were documented in a diary: The symptom score was: 0=none, 1=mild, 2=moderate, 3=severe. Evaluation will be done for the peak of the grass pollen season, defined by those 30 consecutive days per center with the highest local grass pollen counts (according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) measured in the nearest pollen count station in that region.
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 20 Dec 2023.
- Background: PubMed 23584250Rosewich M, Lee D, Zielen S. Pollinex Quattro: an innovative four injections immunotherapy in allergic rhinitis. Hum Vaccin Immunother. 2013 Jul;9(7):1523-31. doi: 10.4161/hv.24631. Epub 2013 Apr 12.
- Results publication: PubMed 24761804Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.
- Individual participant dataSharing planned: No
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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.
Matthias Kramer, Prof. Dr. study director
Bencard Allergie GmbH
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Prof. Dr. Ralph Mösges.
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 2 inclusion and 1 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Assessment of the efficacy of Pollinex® Quattro based on the Combined Symptom and Medication Score (CSMS) (Pfaar et al., 2014). (time frame: 3 months). 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 NCT02579720, which also lists 2 linked publications.
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 20 Dec 2023.