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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

March 29, 2012
April 29, 2013
December 2011
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01568190 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy
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. The frequency of patients with adverse reactions will be the primary endpoint.
Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Rhinitis Due to Dust Mite
Biological: AVANZ MITE
Immunotherapy Dermatophagoides mix
Experimental: AVANZ
Intervention: Biological: AVANZ MITE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01568190
2011-002017-11, 2011-002017-11
No
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Principal Investigator: ANA I TABAR, MD HOSPITAL VIRGEN DEL CAMINO - PAMPLONA
ALK-Abelló A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP