Andosan in Allergic and Asthma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma; Allergic Rhinoconjunctivitis; Immune Tolerance
• Intervention / Treatment: Dietary supplement: Andosan; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Viken
    • Lørenskog, Viken, Norway, 1478
      • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Andosan; 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; See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.
Placebo Comparator: Placebo; 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; drinking water with food colour

What is the study measuring?

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
Immunoglobulin E in serum	difference in concentration before and after intervention	four weeks
Passive basophil cell activation in serum	Difference in activation of basophil cells measured in serum before and after intervention	four weeks

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Oslo University Hospital; ImmunoPharma AS
• Investigators: Principal Investigator: Faiza Mahmood, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: SLIT; ASIT; Andosan
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 20/01869

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No