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An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy (AV-M-01)

Primary Purpose

Allergic Rhinitis Due to Dust Mite

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

AVANZ MITE

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Dust Mite focused on measuring House dust mites sensitisation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients 18-65 years of age.
A clinical history of HDM induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
Positive SPT to Dermatophagoides pteronyssinus (Der pte) or Dermatophagoides farinae (Der far) (wheal diameter ≥ 3 mm).
A positive specific IgE against Der pte or Der far (≥Class 2; ≥0.70 KU/L) documenting in the last 5 years.

Exclusion Criteria:

FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
Uncontrolled or severe asthma.
A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen, to which the subject is regularly exposed and sensitized.
History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication). Please, see Table 4.
Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
Previous treatment by other allergen concomitant IT or immunotherapy with HDM extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
History of severe and recurrent angioedema.
Any contraindication according to the Investigator Brochure (IB).
Use of an investigational drug within 30 days prior to screening.

Sites / Locations

Hospital Virgen Del Camino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVANZ

Arm Description

AVANZ Mites

Outcomes

Primary Outcome Measures

Frequency of patients with adverse reactions.

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Secondary Outcome Measures

Frequency of patients with systemic reactions according to EAACI classification

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Full Information

NCT ID

NCT01568190

First Posted

March 29, 2012

Last Updated

January 5, 2015

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT01568190

Brief Title

An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy

Acronym

AV-M-01

Official Title

An Open Trial to Asses the Tolerability of AVANZ Mite Mix Immunotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite mix.

Detailed Description

The frequency of patients with adverse reactions will be the primary endpoint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis Due to Dust Mite

Keywords

House dust mites sensitisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AVANZ

Arm Type

Experimental

Arm Description

AVANZ Mites

Intervention Type

Biological

Intervention Name(s)

AVANZ MITE

Intervention Description

Immunotherapy Dermatophagoides mix

Primary Outcome Measure Information:

Title

Frequency of patients with adverse reactions.

Description

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Time Frame

Participants wil be followed for an expected average of 6 weeks.

Secondary Outcome Measure Information:

Title

Frequency of patients with systemic reactions according to EAACI classification

Description

From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.

Time Frame

Participants wil be followed for an expected average of 6 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients 18-65 years of age. A clinical history of HDM induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry. Positive SPT to Dermatophagoides pteronyssinus (Der pte) or Dermatophagoides farinae (Der far) (wheal diameter ≥ 3 mm). A positive specific IgE against Der pte or Der far (≥Class 2; ≥0.70 KU/L) documenting in the last 5 years. Exclusion Criteria: FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment. Uncontrolled or severe asthma. A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen, to which the subject is regularly exposed and sensitized. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion). Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication). Please, see Table 4. Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis. Previous treatment by other allergen concomitant IT or immunotherapy with HDM extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted). History of anaphylactic shock due to e.g. food, insect venom, exercise or drug. History of severe and recurrent angioedema. Any contraindication according to the Investigator Brochure (IB). Use of an investigational drug within 30 days prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ANA I TABAR, MD

Organizational Affiliation

HOSPITAL VIRGEN DEL CAMINO - PAMPLONA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Virgen Del Camino

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

25898693

Citation

Tabar AI, Gonzalez Delgado P, Sanchez Hernandez C, Basagana Torrento M, Moreno Benitez F, Arina M. Phase II/III clinical trial to assess the tolerability and immunological effect of a new updosing phase of Dermatophagoides mix-based immunotherapy. J Investig Allergol Clin Immunol. 2015;25(1):40-6.

Results Reference

derived

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An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy

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