An Exploratory, Prospective, Non-interventional Study Comparing Biomarker Signatures Between Patients With Asthma and Healthy Volunteers and to Investigate Biomarkers Associated With Known Phenotypes Across Asthma Severities
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 69
- Locations
- 4
- Primary Endpoint
- Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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:
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)
Time Frame: 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)
Time Frame: Baseline (Visit 1)
Level of Interleukin-6 (IL-6) (pg/mL) in blood at baseline (Visit 1) is presented.
Secondary Outcomes
- 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 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))