Andosan in Allergic and Asthma Patients

NCT05192720 | Completed DMC

• 1 other identifier: 20/01869
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma; Allergic Rhinoconjunctivitis; Immune Tolerance

Keywords

ASIT; SLIT; Andosan

Outcome Measures

Primary Outcomes (1)

• FEV1

  Change in FEV1 within-day variation (%) from run-in-period of last five days of intervention.

  20 days

Secondary Outcomes (5)

• Oscillometry

  20 days to four weeks

• Questionnaire ACT

  four weeks

• Questionnaire RQLQ

  four weeks

• Passive basophil cell activation in serum

  four weeks

• Immunoglobulin E in serum

  four weeks

Study Arms (2)

Andosan

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Andosan DIETARY_SUPPLEMENT

See also detailed study design, Mushroom juice based on Agaricus Blazei and two other types of mushroom.

Andosan

Placebo DIETARY_SUPPLEMENT

drinking water with food colour

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy).
• Age above 18.
• Able to understand written and oral Norwegian

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Oslo University Hospital: collaborator
• ImmunoPharma AS: collaborator

Study Sites (1)

Akershus university hospital

Lørenskog, Akershus, 1478, Norway

Location

MeSH Terms

Interventions

AndoSan

Study Officials

• Faiza Mahmood

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patients do not know if they get Andosan or placebo.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Immunology and Transfusion Medicine

Model Details: 25-30 patients in each arm receiving Andosan or placebo.

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: January 14, 2022
• Study Start: August 31, 2021
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

NO (1)