NCT02758548

Brief Summary

The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients. 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
5 countries

12 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

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

March 15, 2016

Last Update Submit

November 13, 2016

Conditions

Atopic Asthma

Keywords

Total IgE measurementNovel Point-of-care test deviceatopic conditionsin vitro diagnostic test

Outcome Measures

Primary Outcomes (1)

  • Total IgE concentration

    Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment. Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment.

    Day 0 or Day 1 (Visit 2: Blood sampling)

Secondary Outcomes (1)

  • Device usability questionnaire response

    Day 0 or Day 1 (Visit 2: Blood sampling)

Study Arms (1)

Capillary Blood Sampling

OTHER

Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples

Procedure: Blood sampleDevice: POCT device

Interventions

Blood samplePROCEDURE

Fingerprick and venous

Capillary Blood Sampling
POCT deviceDEVICE

Investigational device

Capillary Blood Sampling

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are diagnosed with atopic condition
  • Subjects or legal guardians who are able to give informed consent

You may not qualify if:

  • Subjects who have received anti-IgE antibody treatment
  • Subjects who have elevated IgE levels for reasons other than allergic conditions
  • Subjects who are able to give informed consent for participation in the study according to local requirements / law.
  • Subjects who have received anti-IgE antibody treatment
  • Subjects with a suspected or confirmed clinical diagnosis of an atopic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Lübeck, 23552, Germany

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Pisa, PI, 56124, Italy

Location

Novartis Investigative Site

Roma, RM, 00168, Italy

Location

Novartis Investigative Site

Harderwijk, Netherlands, 3840 AC, Netherlands

Location

Novartis Investigative Site

Almelo, 7609 PP, Netherlands

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

Location

Novartis Investigative Site

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Novartis Investigative Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Novartis Investigative Site

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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

March 15, 2016

First Posted

May 2, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

IT(3)ES(2)DE(2)GB(3)NL(2)