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

NCT ID: NCT01568190

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-07-31

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.

Conditions

Allergic Rhinitis Due to Dust Mite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVANZ

AVANZ Mites

Group Type: EXPERIMENTAL

AVANZ MITE

Intervention Type: BIOLOGICAL

Immunotherapy Dermatophagoides mix

Interventions

AVANZ MITE

Immunotherapy Dermatophagoides mix

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ANA I TABAR, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL VIRGEN DEL CAMINO - PAMPLONA

Locations

Hospital Virgen Del Camino

Pamplona, Navarre, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25898693 (View on PubMed)

Other Identifiers

2011-002017-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2011-002017-11

Identifier Type: -

Identifier Source: org_study_id