NCT02512653

Brief Summary

Biological Standardization of Cupressus arizonica Allergen Extract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

July 29, 2015

Last Update Submit

June 17, 2016

Conditions

Allergy to Tree Pollen

Keywords

Allergy to Cupressus pollen

Outcome Measures

Primary Outcomes (1)

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

    Test sites should be inspected and recorded 15-20 min after application

Study Arms (1)

1

EXPERIMENTAL

Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control

Biological: Cupressus arizonica

Interventions

Cupressus arizonicaBIOLOGICAL

Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject has provided written informed consent, appropriately signed and dated by subject.
  • Subject can be male or female of any race and ethinic group.
  • Age 18 years and 60 years ata the study inclusión day.
  • Positive clinical history of inhalatory allergy to Cupressus arizonica.
  • A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
  • A positive prick test with positive control of histamine 10 mg/ml.
  • A positive test for specific IgE to Cupressus arizonica.

You may not qualify if:

  • Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
  • Use of drugs that may interfere before and after with the skin reactions.
  • Treatment with certain drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario de Fuenlabrada

Fuenalabrada, Madrid, 28942, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Study Officials

  • Lena Erbiti

    Laboratorios Leti, S.L.U

    STUDY CHAIR

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

July 29, 2015

First Posted

July 31, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

ES(2)