Asthma Biomarker Study

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Procedure: Biofluid sampling

Detailed Description

Purpose:

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • 352.2087.44001 Boehringer Ingelheim Investigational Site
  • London, United Kingdom
    • 352.2087.44004 Boehringer Ingelheim Investigational Site
  • Manchester, United Kingdom
    • 352.2087.44002 Boehringer Ingelheim Investigational Site
  • Southampton, United Kingdom
    • 352.2087.44003 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthma and healthy subject

Description

Inclusion criteria:

Body mass index (BMI) >=18 and <= 40 Non-smokers or ex-smokers with a cigarette smoking history of <= 10 pack years and smoking cessation for at least one year prior to enrolment Able to perform all trial related procedures including acceptable spirometry and production of induced sputum samples

Additional inclusion criteria for subject with asthma:

A minimum of one year history of asthma (physician diagnosed). Forced Expiratory Volume in one second (FEV1) reversibility of at least 12% above baseline at screening, unless documented in prior 12 months Methacholine response: concentration of <=8mg/ml to decrease FEV1 by 20% (PC20) at screening, unless documented in prior 12 months Stable asthma treatment for a period of 3 months (mild to moderate asthma) or 4 weeks (severe asthma).

Further Inclusion criteria apply.

Exclusion criteria:

Significant conditions or medical conditions that could influence the results of the study or the patient's ability to participate in the study Malignancy requiring resection, radiation or chemotherapy within 5 years prior to screening Planned surgery during the trial Blood donation of more than 400ml within 4 weeks of starting trial or during the trial Subjects unable or unwilling to comply with the medication, lifestyle or dietary requirements of the trial Pregnant or nursing women History of cystic fibrosis Clinically significant bronchiectasis Acute or chronic infections including hepatitis, HIV and tuberculosis Thoracotomy with pulmonary resection Current significant alcohol or drug abuse Inability to produce sputum samples of sufficient quality Subjects with a sputum neutrophil count greater than 10 million cells per ml Subjects who have taken an investigational drug within 3 months or 6 half-lives of the therapeutic intervention prior to Visit 1

Additional exclusion criteria for asthma patients:

Respiratory tract infection or asthma exacerbation in the 6 week period prior to Visit 1 (patients with mild to moderate asthma should be exacerbation free for a period of 12 months prior to Visit 1.

Patients with documented non-compliance to prescribed asthma controller therapy Treatment with biological agents (other than Xolair for severe asthma) within four months prior to Visit 1 Patients who have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1 or who are currently in a pulmonary rehabilitation program

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	Procedure: Biofluid sampling
Severe asthma
Mild asthma
Moderate asthma

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at 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.	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)	Level of Interleukin-6 (IL-6) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.	follow-up visit 28 days after baseline (Visit 2)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Synopsis Link

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2015
• Primary Completion (Actual): January 3, 2017
• Study Completion (Actual): January 3, 2017

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 352.2087