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

NCT01568190 | Completed Phase 2

• 1 other identifier: 2011-002017-11
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis Due to Dust Mite

Keywords

House dust mites sensitisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of patients with systemic reactions according to EAACI classification

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

Study Arms (1)

AVANZ

EXPERIMENTAL

AVANZ Mites

Biological: AVANZ MITE

Interventions

AVANZ MITE BIOLOGICAL

Immunotherapy Dermatophagoides mix

AVANZ

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Hospital Virgen Del Camino

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• 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.

  PMID: 25898693 DERIVED

Study Officials

• ANA I TABAR, MD

  HOSPITAL VIRGEN DEL CAMINO - PAMPLONA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

ES (1)