Clinical trial NCT01568190: An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy
Official title: An Open Trial to Asses the Tolerability of AVANZ Mite Mix Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Rhinitis Due to Dust Mite
Keywords: House dust mites sensitisation
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Frequency of patients with adverse reactions.
timeFrame: Participants wil be followed for an expected average of 6 weeks.
Secondary outcomes:
measure: Frequency of patients with systemic reactions according to EAACI classification
timeFrame: Participants wil be followed for an expected average of 6 weeks.
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Virgen Del Camino
state: Navarra
Study officials:
affiliation: HOSPITAL VIRGEN DEL CAMINO - PAMPLONA
name: ANA I TABAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.