Rhinitis, AllergicNCT04389034
Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels
An observational study of Rhinitis, Allergic and Respiratory Tract Infections, run by Allergy Therapeutics at 1 site in Germany.
Trial summary
Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Respiratory Tract Infections, Allergy
- What is being tested?
- Pollinex Quattro with tree- and grass pollen extracts and their mixtures
- How many people
- 113 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2020to 5 Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Allergic patients ≥ 18 years with IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
Who may be able to join
- Patients ≥ 18 years
- Diagnosis of IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
- completed allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts or their mixtures according to SMPC effective during immunotherapy
Who cannot join
- Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy
- no additional allergen-specific immunotherapy with another product than Pollinex Quattro
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Collection Based on Patient Records and Questionaire Based Data of Therapy Results of Allergen-specific Immunotherapy With Pollinex Quattro With Tree and/or Gras Pollen Extracts and Their Mixtures
Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.
Read the detailed description
In this non-interventional study, the change in level of allergen-specific IgE before and after 3 or more years of allergen-specific immunotherapy with Pollinex Quattro in a patient population with tree and/or grass pollen induced pollinosis and/or asthma will be analyzed. In addition, the change in medication usage, asthma status for asthmatic patients after 3, 4 or 5 years of allergen specific immunotherapy will be evaluated. Furthermore, patients will be asked for their change in quality of life after therapy end.
- Conditions
- Rhinitis, Allergic, Respiratory Tract Infections, Allergy, Allergic Asthma, Allergic Conjunctivitis
- Being tested
- Pollinex Quattro with tree- and grass pollen extracts and their mixtures
- Medical subject headings
- Rhinitis, Allergic, Respiratory Tract Infections, Hypersensitivity, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pollinex Quattro with tree- and grass pollen extracts and their mixturesDrug
retrospective analysis of patient records of allergen-specific immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Adults | Patients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy Receives: Drug: Pollinex Quattro with tree- and grass pollen extracts and their mixtures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in allergen specific IgE after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Secondary outcomes (6)
Change in medication usage after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Efficacy
Measured: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start22 Apr 2020
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389034
- Sponsor's protocol ID
- PQ EAST V1.0
- Status last verified
- Feb 2021
- First submitted
- 22 Apr 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection Based on Patient Records and Questionaire Based Data of Therapy Results of Allergen-specific Immunotherapy With Pollinex Quattro With Tree and/or Gras Pollen Extracts and Their Mixtures
- ClinicalTrials.gov ID
- NCT04389034
- Acronym / sponsor ID
- PQ EAST V1.0
- Conditions
- Rhinitis, Allergic, Respiratory Tract Infections, Allergy, Allergic Asthma, Allergic Conjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Allergy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 15 May 2020 (actual)
- 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.
Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.
Detailed description
In this non-interventional study, the change in level of allergen-specific IgE before and after 3 or more years of allergen-specific immunotherapy with Pollinex Quattro in a patient population with tree and/or grass pollen induced pollinosis and/or asthma will be analyzed. In addition, the change in medication usage, asthma status for asthmatic patients after 3, 4 or 5 years of allergen specific immunotherapy will be evaluated. Furthermore, patients will be asked for their change in quality of life after therapy end.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Drug: Pollinex Quattro with tree- and grass pollen extracts and their mixturesPatients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allergic patients ≥ 18 years with IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
Key inclusion criteria (3 listed)
- Patients ≥ 18 years
- Diagnosis of IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
- completed allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts or their mixtures according to SMPC effective during immunotherapy
Key exclusion criteria (2 listed)
- Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy
- no additional allergen-specific immunotherapy with another product than Pollinex Quattro
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 |
|---|---|---|
| Pollinex Quattro with tree- and grass pollen extracts and their mixturesretrospective analysis of patient records of allergen-specific immunotherapy | Drug | Adults |
Primary outcome
Change in allergen specific IgE after allergen-specific immunotherapy
Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Efficacy
6 secondary outcomes
Change in medication usage after allergen-specific immunotherapy
Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy
Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy
Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Time frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Time frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Time frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
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 8 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic and Respiratory Tract Infections, run by Allergy Therapeutics at 1 site in Germany.
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 3 inclusion and 2 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 8 Feb 2021. 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 Germany. 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.
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?
Change in allergen specific IgE after allergen-specific immunotherapy (time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021.