Biological Standarization of Cupressus Arizonica Allergen... | NCT02512653

Studies
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

NCT02512653

Sponsor

Laboratorios Leti, S.L.

Status

Completed

Last Update Posted

Jun 20, 2016Estimated

Enrollment

33Actual

Phase

Phase 2

Conditions

Allergy to Tree Pollen

Interventions

Cupressus arizonica

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jul 29, 2015

First Submission Date that Met QC Criteria

Jul 30, 2015

First Posted Date

Jul 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2016

Last Update Posted Date

Jun 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Biological Standardization of Cupressus arizonica Allergen Extract.

Detailed Description

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control	Biological: Cupressus arizonica

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cupressus arizonica	Biological	Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lena Erbiti	Laboratorios Leti, S.L.U	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario de Fuenlabrada		Fuenalabrada	Madrid	28942	Spain
Hospital Universitario Puerta de Hierro