Allergic Rhinitis Due to Dust Mite
Conditions
Keywords
House dust mites sensitisation
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.
Interventions
BIOLOGICALAVANZ MITE
Immunotherapy Dermatophagoides mix
Sponsors
ALK-Abelló A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of patients with adverse reactions. | Participants wil be followed for an expected average of 6 weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of patients with systemic reactions according to EAACI classification | Participants wil be followed for an expected average of 6 weeks. | 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. |
Countries
Spain
Outcome results
None listed