Allergic Asthma, Allergic Rhinoconjunctivitis, Immune Tolerance
Conditions
Keywords
ASIT, SLIT, Andosan
Brief summary
Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease. A prospective randomised study comparing the mushroom extract with placebo.
Detailed description
Asthma and allergy are increasing in Norway and Western countries. Treatment is still mostly symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as Andosan™, have been shown to protect against asthma and allergy in murine models by changing the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune system. Positive effects on allergy were also shown in a RCT on blood donors with selfreported allergy. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. The aim of this study is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking Andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (ASIT). If the extract shows effect on these patients it support the hypotheses that Andosan helps against atopic diseases and facilitate the shift from Th-2 to Th-1 responses at a cellular level.
Interventions
DIETARY_SUPPLEMENTAndosan
See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.
DIETARY_SUPPLEMENTPlacebo
drinking water with food colour
Sponsors
Oslo University Hospital
ImmunoPharma AS
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
the patients do not know if they get Andosan or placebo.
Intervention model description
25-30 patients in each arm receiving Andosan or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy). * Age above 18. * Able to understand written and oral Norwegian
Exclusion criteria
\- none other than not meeting the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | 20 days | Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oscillometry | 20 days to four weeks | change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry. |
| Questionnaire ACT | four weeks | Change in asthma symptoms, as measured by the asthma control test |
| Questionnaire RQLQ | four weeks | Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality) |
| Passive basophil cell activation in serum | four weeks | Difference in activation of basophil cells measured in serum before and after intervention |
| Immunoglobulin E in serum | four weeks | difference in concentration before and after intervention |
Countries
Norway
Outcome results
None listed