Asthma Biomarker Study

NCT02392481 | Completed Results

• 1 other identifier: 352.2087
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 4

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

Study Arms (4)

Healthy subjects

Procedure: Biofluid sampling

Mild asthma

Moderate asthma

Severe asthma

Interventions

Biofluid sampling PROCEDURE

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthma and healthy subject

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

352.2087.44001 Boehringer Ingelheim Investigational Site

Leicester, United Kingdom

Location

352.2087.44004 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

352.2087.44002 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

352.2087.44003 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and sputum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The study is considered exploratory in nature as the definitive power needed to assess yet unknown endotypes cannot be prospectively specified. The study is, however, adequately designed as hypothesis generating study informing interventional studies

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 19, 2015
• Study Start: July 16, 2015
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2017-12

Locations

GB (4)