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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014