Andosan in Allergic and Asthma Patients

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05192720
• Other study ID #: 20/01869
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• 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 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.

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). 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.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinoconjunctivitis
• Asthma
• Immune Tolerance

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	Mast cell activation in serum	Difference in activation of mast cells measured in serum before and after intervention	four weeks
Secondary	Immunoglobulin E in serum	difference in concentration before and after intervention	four weeks
Secondary	Eosinophiles	difference in eosinophile count before and after intervention.	20 days