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

Allergic Rhinitis Due to Dust Mite Clinical Trial

— AV-M-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568190
• Other study ID #: 2011-002017-11
• Secondary ID: 2011-002017-11
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 29, 2012
• Last updated: January 5, 2015
• Start date: December 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2015
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

The frequency of patients with adverse reactions will be the primary endpoint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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, ß-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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Dust Mite

Intervention

Biological:
• AVANZ MITE
Immunotherapy Dermatophagoides mix

Locations

Country	Name	City	State
Spain	Hospital Virgen Del Camino	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Frequency of patients with systemic reactions according to EAACI classification	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.	Yes