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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05192720
Other study ID # 20/01869
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date February 28, 2023

Study information

Verified date June 2024
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 28, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Andosan
See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.
Placebo
drinking water with food colour

Locations

Country Name City State
Norway Akershus university hospital Lørenskog Viken

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Akershus ImmunoPharma AS, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary FEV1 Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention. 20 days
Secondary Oscillometry change in small airway obstruction as measured by the R5Hz and R5-20Hz level in oscillometry. 20 days to four weeks
Secondary Questionnaire ACT Change in asthma symptoms, as measured by the asthma control test four weeks
Secondary Questionnaire RQLQ Change in burden of asthma symptoms measured by RQLQ (Respiratory questionnaire of life quality) four weeks
Secondary Passive basophil cell activation in serum Difference in activation of basophil cells measured in serum before and after intervention four weeks
Secondary Immunoglobulin E in serum difference in concentration before and after intervention four weeks
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