Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a Pollen and Dust Mite Mixture.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00665483
First received: April 22, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

Multicenter Skin Prick Test


Condition Intervention Phase
Type I Allergy
Other: Skin Prick Test
Phase 4

Study Type: Interventional
Official Title: Design of Optimally-diagnostic Skin Test Solutions for Diagnosis of Sensitisation to a 6-grass Pollen Mixture, House Dust Mite (Dermatophagoides Pteronyssinus), Birch Pollen, and Mugwort Pollen

Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Optimal trade-off between sensitivity and specificity [ Time Frame: December 2007 - December 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the documentation of adverse events [ Time Frame: January - December 2008 ] [ Designated as safety issue: Yes ]

Study Start Date: March 2007
Study Completion Date: November 2010
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Skin Prick Test
Other: Skin Prick Test
Skin Prick Test

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • anamnesis referring to suspicion of an IgE-mediated allergy
  • positive Skin Prick Test in the medical history to at least one of the investigational allergens with an existing anamnesis

Exclusion Criteria:

  • serious chronic diseases
  • Other perennial allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665483

Locations
Germany
Klinikum Darmstadt
Darmstadt, Hessen, Germany, 64297
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Nicola Wagner, MD Klinikum Darmstadt
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00665483     History of Changes
Other Study ID Numbers: AL0205PR, 2006-005304-14
Study First Received: April 22, 2008
Last Updated: November 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on April 23, 2014