Asthma Biomarker Study

Completed

• Conditions: Asthma
• Interventions: Procedure: Biofluid sampling

• Registration Number: NCT02392481
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of the trial is to explore if any of the biomarkers assessed are sensitively linked to the asthma phenotypes. This would potentially alone or in addition to other clinical or biofluid markers indicate if and how asthma endotypes are linked to phenotype such as eosinophilic, neutrophilic, or paucigranulocytic phenotypes. Further exploratory markers will be analysed for better understanding of physiological levels of proteins and markers playing a role in regard to disease characterization in asthma. As a basis for further development of a biomarker for asthma, The sponsor plans to conduct this exploratory biomarker trial to determine levels and reference ranges of biomarkers potentially associated with asthma phenotypes. The trial aims at generating a panel of serum biomarkers that can be evaluated in subsequent interventional studies. The longitudinal design will be used to ascertain stability and test-retest reliability.

Detailed Description

Purpose:

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Study Start: 2015-07-16
• Primary Completion: 2017-01-03
• Study Completion: 2017-01-03
• Status Verified: 2017-12
• Results First Submitted: 2017-12-13
• Results First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Results First Posted: 2018-08-29
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Biofluid sampling	-

Primary Outcome Measures

Name	Time	Method
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)	Baseline (Visit 1)	Level of Tumour Necrosis Factor-alpha (TNF-α) \[picograms per milliliter (pg/mL)\] in blood at baseline (Visit 1) is presented.
Level of Interleukin-6 (IL-6) in Blood at Baseline (Visit 1)	Baseline (Visit 1)	Level of Interleukin-6 (IL-6) (pg/mL) in blood at baseline (Visit 1) is presented.

Secondary Outcome Measures

Name	Time	Method
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)	follow-up visit 28 days after baseline (Visit 2)	Level of Tumour Necrosis Factor-alpha (TNF-α) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.
Level of Interleukin-6 (IL-6) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)	follow-up visit 28 days after baseline (Visit 2)	Level of Interleukin-6 (IL-6) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.

Trial Locations

Locations (4)

352.2087.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 Leicester, United Kingdom

352.2087.44004 Boehringer Ingelheim Investigational Site; 🇬🇧 London, United Kingdom

352.2087.44002 Boehringer Ingelheim Investigational Site; 🇬🇧 Manchester, United Kingdom

352.2087.44003 Boehringer Ingelheim Investigational Site; 🇬🇧 Southampton, United Kingdom