|- candidate number||8932|
|- NTR Number||NTR2692|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jan-2011|
|- Secondary IDs||NL25370.078.09 / 2009-011827-30 ; CCMO / EudraCT|
|- Public Title||Onderzoek naar de kosten en werkzaamheid van injectiekuren (immunotherapie) bij patiënten met een allergie voor boompollen, graspollen en/of huisstofmijt.|
|- Scientific Title||Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis.|
|- hypothesis||1. Cost-effectiveness: Subcutaneous immunotherapy (SCIT) with tree pollen (TP), grass pollen (GP), house dust mites (HDM) or combinations is cost-effective compared to usual care (UC) only.|
2. Clinical effectiveness: SCIT with more than one allergen is clinically more effective - with respect to symptom improvement, medication reduction and health related quality of life - than usual care.
|- Healt Condition(s) or Problem(s) studied||Cost-effectiveness , Immune therapy, Adults, Allergic rhinitis|
|- Inclusion criteria||1. 18-45 years;|
2. 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:
A. Specific IgE >= 0.7 kU/l (Phadia);
B. 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);
C. 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.
3. Signed informed consent.
|- Exclusion criteria||1. Severe/instable asthma:|
A. FEV1 <70% predicted and/or FEV1/FVC <70;
B. Asthma exacerbation requiring prednisolon treatment, visit to a first aid station and/or hospitalisation in the preceding 12 months.
2. Specific IgE >= 0.7 kU/l to animals the patient is in daily contact with;
3. Immunotherapy in preceding 5 years;
4. Anatomical disorders of the nose;
5. Language barrier;
6. No daily access to internet (because of web based questionnaires);
7. Contraindications to immunotherapy (according to international guidelines).
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||30-nov-2011|
|- Target number of participants||240|
|- Interventions||Subcutaneous immunotherapy with tree pollen and/or grass pollen and/or house dust mite extract (Alutard SQ 197/293/503; ALK-Abello) + usual care vs usual care only.|
|- Primary outcome||1. 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. In case of multiple allergens treatment success is defined as follows: the response option “much better” or “completely recovered” for at least one allergen and for the remaining allergens “no change”, “better”, “much better” or “completely recovered;|
2. Clinical effectiveness:
A. The mean daily total rhinitis symptom score in the first year for multi-sensitized patients;
B. 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) For tree and grass pollen: only days with sufficient exposure will be analyzed;
C. The intensity of 4 rhinitis symptoms (nasal blockage, watery runny nose, sneezing, itching nose) will be subjectively assessed by the patient on a scale grading from 0 = no complaints to 3 = serious complaints.
|- Secondary outcome||1. Cost-effectiveness:|
A. The costs per unit of difference between groups in the mini Rhinitis Quality of Life Questionnaire score (mini-RQLQ-score; disease specific quality of life) during the allergen peak period in year one and two;
B. The costs per symptom-free day during the first and the second year;
C. The cost per QALY, using the EQ-5D and SF-36v2 questionnaire to derive utilities.
2. Clinical effectiveness:
A. Symptom scores after two years and in several subgroups;
B. Percentage of days with rescue medication use;
C. Percentage of ‘well days’;
D. Visual analogue scale;
E. Disease specific quality of life (mini-RQLQ);
F. Generic quality of life (EQ-5D and SF-36);
G. Global assessment;
J. IgG and IgG4.
|- Trial web site||www.airforce-onderzoek.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. Esther Röder|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MD. PhD. Roy Gerth Wijk, van|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||13-jan-2011 - 21-jan-2011|