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Clinical Trials/RPCEC00000240
RPCEC00000240
Recruiting
Phase 2

Clinical trial of combined immunotherapy con with allergenic extracts Dermatophagoides pteronyssinus (VALERGEN-DP) and Blomia tropicalis (VALERGEN-BT) by sublingual route in sensitized asthmatic adults (version 1.3).

ational Center of Bioproducts (BIOCEN)0 sites120 target enrollmentFebruary 17, 2017
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ConditionsAsthmaBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesEnvironmental Illness

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Asthma
Sponsor
ational Center of Bioproducts (BIOCEN)
Enrollment
120
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 17, 2017
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Center of Bioproducts (BIOCEN)

Eligibility Criteria

Inclusion Criteria

  • •1\. Asthmatic allergic patients with positive responses during the preliminary survey in the following aspects: family and personal history of atopy, clinical symptoms only triggered when exposed to dust at home, mainly indoors, when getting up in the morning or going to bed at night.
  • •2\. Skin test positive with similar diameter (difference not mayor of 2 mm) to allergenic extracts of D. pteronyssinus and B. tropicalis, VALERGEN, 20,000 BU/ml.
  • •3\. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, according the clinical\-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Consensus on Asthma Diagnosis and Treatment (GINA).
  • •4\. Age between 18 and 45 years.
  • •5\. Any gender and skin color.
  • •6\. Patients expressing their consent in writing to participate in clinical trial.

Exclusion Criteria

  • •1\. Patients on allergenic extract immunotherapy during the two preceding years.
  • •2\. Patients classified as intermittent or severe persistent asthmatics after being interviewed.
  • •3\. Patients with a diagnosed autoimmune disease of any kind.
  • •4\. Generalized severe eczema.
  • •5\. Patients with diagnosed tumor disease.
  • •6\. Patients on beta\-blocker treatment.
  • •7\. Patients with psychiatric disorders.
  • •8\. Patients not cooperating with treatment.
  • •9\. Patients who, at least one year before the study, needed immunestimulant or immunesuppressor treatment (no corticosteroids), including interferon and cyclosporine A.
  • •10\. Pregnancy and breastfeeding.

Outcomes

Primary Outcomes

Not specified

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