Trial | NCT02123316  Report issue

Title

Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis
Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo.

The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.
Study Started
Jan 31
2010
Primary Completion
Apr 30
2014
Study Completion
Apr 30
2014
Last Update
Mar 31
2016
Estimate

Biological Pangramin Plus D. pteronyssinus

Subcutaneous immunotherapy with Dermatophagoides pteronyssinus

Biological Placebo

Placebo for subcutaneous injection

Pangramin Plus D. pteronyssinus Active Comparator

Pangramin Plus D. pteronyssinus 100% for subcutaneous injection

Placebo Placebo Comparator

Placebo for subcutaneous injection

Criteria 

Inclusion Criteria:

Prior to study specific examinations the patient has to give his/her written informed consent.
Local allergic rhinitis induced by Dermatophagoides pteronyssinus (DP).
Age: 18-55.
Negative skin prick-test to DP
Positive nasal allergen provocation test to DP (NAPT-DP) and/or nasal specific IgE (sIgE) to DP>0.35 kU/L
If applicable negative urine pregnancy test and willingness to use effective form of contraception for the duration of involvement in the study.

Exclusion Criteria:

Severe immunopathological or immunodeficiencies diseases.
Treatment with beta-blockers, even when administered topically
Severe psychological disorders
Severe Atopic Dermatitis
FEV1 <70% predicted after appropriate pharmacological treatment
History of hypersensitivity or intolerance to excipients and / or trial medication or other medication to be used for protocol
Inability to adequately perform diagnostic tests or treatment
Awareness of other inhaled allergens (perennial or seasonal) clinically relevant to the subject and that may interfere with the response evaluation
Treatment with immunotherapy in the 5 years prior to his inclusion in the study
No Results Posted