Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

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

* Severe/instable asthma:
- FEV1 <=70% predicted and/or FEV1/FVC <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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cost-effectiveness: the costs per successfully treated patient, based on a<br /><br>global assessment of efficacy by the patient after the allergen peak exposure<br /><br>period in year 2 for the group that starts in 2009 and year one for the group<br /><br>that starts in 2010.<br /><br>Clinical effectiveness: the difference in mean daily total nasal symptom scores<br /><br>for multi-sensitized patients in the peak exposure periods after one year. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cost-effectiveness: the costs per symptom-free day, the costs per QALY, the<br /><br>costs per unit of difference between groups in the RQLQ score (disease specific<br /><br>quality of life).<br /><br>Clinical effectiveness: the difference in mean daily total symptom scores after<br /><br>two years and in several subgroups; percentage of days with anti-allergic<br /><br>medication use, the percentage of well days, visual analogue scale; disease<br /><br>specific quality of life; global assessment; safety and adherence.</p><br>