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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Dust Mite
• Intervention / Treatment: Biological: AVANZ MITE

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Virgen del Camino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVANZ; AVANZ Mites	Biological: AVANZ MITE; Immunotherapy Dermatophagoides mix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants wil be followed for an expected average of 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants wil be followed for an expected average of 6 weeks.

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Investigators: Principal Investigator: ANA I TABAR, MD, HOSPITAL VIRGEN DEL CAMINO - PAMPLONA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: House dust mites sensitisation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 2011-002017-11 (EudraCT Number)