Andosan in Allergic and Asthma Patients

Study Overview
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Brief Summary
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Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy or who have asthma proven by metacholine provocation test, experience clinical and biochemical improvement in their disease. A prospective randomised study comparing the mushroom extract with placebo.

Detailed Description
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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). iii) Investigate if Andosan taken for two weeks has any effect on bronchial reactivity measured through spirometry done five days (as home spirometry twice daily) before and after treatment with Andosan in patients proven to have asthma with bronchial provocation test. 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.

Official Title
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Effect of Supplementary Treatment With Agaricus Blazei Based Mushroom Extract, Andosan, on Patients With Asthma and Allergy

Conditions
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Allergic Asthma, Allergic Rhinoconjunctivitis, Immune Tolerance

Intervention / Treatment
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* Dietary Supplement: Andosan
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FOR PART 1 Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy). Age above 18. Able to understand written and oral Norwegian FOR PART 2 Positive metacholine provocation test (Newly diagnosed with asthma) Age above 18. Able to perform spirometry at home independently. Exclusion Criteria: - none other than not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 25-30 patients in each arm receiving Andosan or placebo.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Andosan<br>The Agaricus blazei Murill-based mushroom extract, Andosan™, is given as one dosage 100 ml/day orally for 1 month. The intervention solution is given in a neutral plastic container | Dietary Supplement: Andosan<br>* See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.<br>|
| Placebo Comparator: Placebo<br>The placebo is drinking water with brownish food coloring, given as one dosage 100 ml/day orally for 1 month. The placebo solution is given in a neutral plastic container (same as for intervention/experimental solution). | Dietary Supplement: Placebo<br>* drinking water with food colour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention. | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oscillometry | change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry. | 20 days to four weeks | 
| Questionnaire ACT | Change in asthma symptoms, as measured by the asthma control test | four weeks | 
| Questionnaire RQLQ | Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality) | four weeks | 
| Mast cell activation in serum | Difference in activation of mast cells measured in serum before and after intervention | four weeks | 
| Immunoglobulin E in serum | difference in concentration before and after intervention | four weeks | 
| Eosinophiles | difference in eosinophile count before and after intervention. | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASIT, SLIT, Andosan