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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01568190
First received: March 29, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite mix. The frequency of patients with adverse reactions will be the primary endpoint.


Condition Intervention Phase
Allergic Rhinitis Due to Dust Mite
 Biological: AVANZ MITE
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial to Asses the Tolerability of AVANZ Mite Mix Immunotherapy

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Frequency of patients with adverse reactions. [ Time Frame: Participants wil be followed for an expected average of 6 weeks. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Participants wil be followed for an expected average of 6 weeks. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 102
Study Start Date: December 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVANZ Biological: AVANZ MITE
Immunotherapy Dermatophagoides mix

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568190

Locations
Spain
Hospital Virgen Del Camino
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: ANA I TABAR, MD HOSPITAL VIRGEN DEL CAMINO - PAMPLONA
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01568190     History of Changes
Other Study ID Numbers: 2011-002017-11, 2011-002017-11
Study First Received: March 29, 2012
Last Updated: April 29, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by ALK-Abelló A/S:
House dust mites sensitisation

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013