NCT01984528

Brief Summary

The objetive of this study is to determine the minimum amount of Alternaria alternata allergen extract producing in a positive skin reaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 5, 2015

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

November 8, 2013

Last Update Submit

January 2, 2015

Conditions

Allergy to Alternaria Fungus

Keywords

ImmunotherapySkin prick testStandardizationAlternaria alternata

Outcome Measures

Primary Outcomes (1)

  • Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.

    Test sited chould be inspected and recorded 15-20 min after appliction

Study Arms (1)

Prick Test

EXPERIMENTAL

Alternaria alternata allergen extract Positve control Negative control

Biological: four differente concentrations of Alternaria alternata allergen extract, positive control and negative control

Interventions

four differente concentrations of Alternaria alternata allergen extract, positive control and negative controlBIOLOGICAL

This concentrations will be tested in every patient in duplicate on the volar surface of the forearm.

Also known as: Four concentratios of Alternaria alternata together with a positive and negative control.
Prick Test

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive clinical history of inhalatory allergy to Alternaria alternata. Subject has provided written informed consent, appropriately signed and dated by the subject.
  • The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ≥ 3 mm.

You may not qualify if:

  • Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (for example: fungal extracts) Use of drugs that may interfere with the skin reactions (e.g., antihistamines). Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).
  • Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 1 or 2.
  • Dermographism affecting the skin area at the test site at either study visit. Atopic dermatitis affecting the skin area at the test site at either study visit.
  • Urticaria affecting the skin area at the test site at either study visit. Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
  • Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
  • Severe psychiatric, psychological or neurological disorders. Abuse of alcohol, drugs or medicines in the previous year. Subjects who have received anti-IgE (Omalizumab).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Clínico Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Study Officials

  • Lena Erbiti

    Laboratorios Leti, S.L.U

    STUDY CHAIR

  • Santiago Quirce, MD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

  • José Damian López, MD

    HOSPITAL CLÍNICO UNIVERSITARIO VIRGEN DE LA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 14, 2013

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 5, 2015

Record last verified: 2013-05

Locations

ES(2)