allergic rhinitis hay fever
Conditions
Interventions
SCIT with TP, GP, HDM or a combination plus UC or UC only, for 2 years (start
autumn 2009) or 1 year (start autumn 2010).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
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 (RSS) >=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 (QOLs). Protocol exception: A sensitization for an allergen (specific IgE >=0.7 kU/l (Phadia)) is also considered clinically relevant and the rhinitis moderate-severe if: RSS=3 and QOLs >=3 or QOLs=0 and RSS >=9. * Signed informed consent
Exclusion criteria
Exclusion criteria: * Severe/instable asthma: - FEV1 = 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 |
|---|---|
| Cost-effectiveness: the costs per successfully treated patient, based on a global assessment of efficacy by the patient after the allergen peak exposure period in year 2 for the group that starts in 2009 and year one for the group that starts in 2010. Clinical effectiveness: the difference in mean daily total nasal symptom scores for multi-sensitized patients in the peak exposure periods after one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness: the costs per symptom-free day, the costs per QALY, the costs per unit of difference between groups in the RQLQ score (disease specific quality of life). Clinical effectiveness: the difference in mean daily total symptom scores after two years and in several subgroups; percentage of days with anti-allergic medication use, the percentage of *well days*, visual analogue scale; disease specific quality of life; global assessment; safety and adherence. | — |
Countries
Netherlands
Outcome results
None listed