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Clinical Trials/RPCEC00000127
RPCEC00000127
Suspended
Phase 2

Clinical trial with allergenic extracts Dermatophagoides pteronyssinus (VALERGEN-DP) and Blomia tropicalis (VALERGEN-BT) by subcutaneous therapeutic use in sensitized asthmatic adults. Version 04.” - SCIT-C-VALERGEN-DP-BT-Asthma-Adults-Phase II

ational Center of Bioproducts (BIOCEN)0 sites120 target enrollmentApril 13, 2012
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Overview

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

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 13, 2012
End Date
June 6, 2011
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 16 and 45 years.
  • •5\. Any sex and color skin.
  • •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 tumoral disease.
  • •6\. Patients on betablocker treatment.
  • •7\. Patients with psychiatric disorders.
  • •8\. Patients not cooperating with treatment.
  • •9\. Patients who, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A.
  • •10\. Pregnancy and breastfeeding.

Outcomes

Primary Outcomes

Not specified

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