An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy (NCT01568190) | Clinical Trial Compass
CompletedPhase 2/3
An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy
Spain102 participantsStarted 2011-12
Plain-language summary
The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite mix.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Previou…
What they're measuring
1
Frequency of patients with adverse reactions.
Timeframe: Participants wil be followed for an expected average of 6 weeks.