Allergic Rhinitis Clinical Trial
Official title:
Non-interventional Study A Multicentre Observational Study for Revaccination With Pollinex® Quattro in Patients With a Recurrent Grass Pollen Allergy
Verified date | December 2023 |
Source | University Hospital of Cologne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Contraindications according to the patient information leaflet |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Prof. Dr. Ralph Mösges | University Hospital of Cologne |
Pfaar 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. Recomm — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
3 months |
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