Allergic rhinitis. MedDRA version: 9.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Trade Name: Alutard SQ Huisstofmijten (SQ 503)
Pharmaceutical Form: Suspension for injection
Trade Name: Alutard SQ Pollen (tree pollen SQ 197 + grass pollen SQ 293)
Pharmaceutical Form: Suspension f
Sponsors
ErasmusMC-University Medical Center Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * 18-45 years * Clinically relevant moderate to severe allergic rhinitis due to a sensitization for one, two or three of the following allergens: tree pollen (TP), grass pollen (GP) and/or house dust mite (HDM). For each allergen (TP, GP, HDM) the following 3 criteria are evaluated. A sensitization for an allergen is considered clinically relevant and the rhinitis moderate-severe if: 1) specific IgE =0.7 kU/l (Phadia) 2) retrospective total symptom score =4: participants will score 4 nose symptoms (sneezing, itching nose, watery running nose, nasal blockage) during the previous peak exposure period (TP April 1-May 15; GP May 15-June 30; HDM September 1-October 31) on a 0-3 scale (0=none, 1=mild, 2=moderate, 3=severe; maximum total score=12). 3) the presence of =1 of the following complaints due to rhinitis during the previous season: sleep disturbance; impairment of daily activities; leisure and/or sport; impairment of school or work; troublesome symptoms. * Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Severe/instable asthma: - FEV1 =70% - Asthma exacerbation requiring prednisolon treatment, visit to a first aid station and/or hospitalisation in the preceding 12 months. * Specific IgE = 0.7 kU/l to animals the patient is in daily contact with * Immunotherapy in preceding 5 years * Anatomical disorders of the nose * Language barrier * No daily access to internet (because of web based questionnaires) * Contraindications to immunotherapy (according to international guidelines; i.e. history of anaphylaxis; immunosuppressive treatment etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cost-effectiveness: Is subcutaneous immunotherapy (SCIT) with tree pollen (TP), grass pollen (GP) or house dust mites (HDM) or combinations cost-effective compared to usual care (UC) only? Clinical effectiveness: Is SCIT with more than one allergen clinically more effective - with respect to symptom improvement, medication reduction and health related quality of life - than UC? ;Secondary Objective: What is the adherence to SCIT using retrospective data from the project group, trial based data and data obtained from the PHARMO database?;Primary end point(s): Cost-effectiveness: * The costs per successfully treated patient, where success is based on a global assessment of efficacy by the patient after the allergen peak period in year 2 for the group that starts in 2009 and year one for the group that starts in 2010. * The global assessment of efficacy is based on a rating of general improvement on a 6-point ordinal scale (much worse, a little worse, no change, a little better, much better, completely recovered). The response options “much better” and “completely recovered” define treatment success. Clinical effectiveness: * The mean daily total rhinitis symptom score in the first year for multi-sensitized patients. * Daily symptom scores will be recorded during the peak exposure periods: tree pollen April 1 - May 15; grass pollen May 15 - June 30; house dust mite September 1 - October 30 (if the patient is treated with two or three allergens, symptom scores will be recorded during two or three periods) * The intensity of 4 rhinitis symptoms (sneezing, itching nose, watery runny nose, nasal blockage) will be subjectively assessed by the patient on a scale grading from 0 = no complaints to 3 = serious complaints. | — |
Countries
Netherlands
Outcome results
None listed