Asthma Biomarker Study

Study Overview
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Brief Summary
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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
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Purpose:

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Procedure: Biofluid sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br> | Procedure: Biofluid sampling<br> <br> |
| Mild asthma<br> | |
| Moderate asthma<br> | |
| Severe asthma<br> | |

What is the study measuring?
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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) |