First, to estimate the cost-effectiveness of SCIT with tree pollen (TP), grass pollen (GP), and house dust mites (HDM) - the most prevalent allergies treated with SCIT - or combinations compared with UC. Second, to estimate the clinical efficacy of…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The prevalence of allergic rhinitis is estimated at 23%. Reported annual costs
of allergic rhinitis in different countries vary from ¤ 1,543 to ¤ 4,260 per
adult. Apart from usual care (UC), which consists of symptomatic, anti-allergic
medication, subcutaneous immunotherapy (SCIT) with allergens has proven
long-term effects on symptoms of both rhinitis and asthma. However SCIT is
expensive and its cost-effectiveness has not been proven. Furthermore, no data
are available on the efficacy of SCIT in multi-sensitized patients using more
than one allergen.
Study objective
First, to estimate the cost-effectiveness of SCIT with tree pollen (TP), grass
pollen (GP), and house dust mites (HDM) - the most prevalent allergies treated
with SCIT - or combinations compared with UC. Second, to estimate the clinical
efficacy of SCIT with a combination of two or three allergens (TP/GP/HDM) in
multi-sensitized patients.
Study design
Multicenter randomized controlled open clinical trial with two parallel
treatment groups
Intervention
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).
Study burden and risks
Screening - 1 contact by phone and 1 site visit (45-60 min): questionnaire, one
blood sample, physical examination (length/weight, if applicable nose
inspection) and if applicable one lung function test (spirometry).
During the study - No extra site visits. Participants will be contacted by
phone every 3 months (10 minutes per call). One blood sample after one year.
Diary card in peak exposure period: 6-8 weeks per allergen (5-10 minutes per
day). Questionnaires outside peak exposure period: approximately every 2 months
(15-20 minutes per assessment).
Immunotherapy - The allergen extracts for subcutaneous administration are
registered. Local side effects (itching, redness, swelling) are frequent and
usually mild. Systemic allergic reactions are rare.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-011827-30-NL |
| CCMO | NL25370.078.09 |
| OMON | NL-OMON25681 |