Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis. - Cost-effectiveness of SCIT in allergic rhinitis

• Conditions: Allergic rhinitis.; MedDRA version: 9.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitis

• Registration Number: EUCTR2009-011827-30-NL
• Lead Sponsor: ErasmusMC-University Medical Center Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-08
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

* 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified