AsthmaNCT02392481
Asthma Biomarker Study
An observational study of Asthma, run by Boehringer Ingelheim at 4 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Biofluid sampling
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 16 Jul 2015to 3 Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asthma and healthy subject
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
352.2087.44001 Boehringer Ingelheim Investigational Site
Leicester
352.2087.44004 Boehringer Ingelheim Investigational Site
London
352.2087.44002 Boehringer Ingelheim Investigational Site
Manchester
352.2087.44003 Boehringer Ingelheim Investigational Site
Southampton
About this study
Official title: 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.
Read the detailed description
Purpose:
- Conditions
- Asthma
- Being tested
- Biofluid sampling
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofluid samplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Procedure: Biofluid sampling | |
| Mild asthma | Not described | |
| Moderate asthma | Not described | |
| Severe asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Level of Tumour Necrosis Factor-alpha (TNF-α) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.
Measured: 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.
Measured: follow-up visit 28 days after baseline (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start16 Jul 2015
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392481
- Sponsor's protocol ID
- 352.2087
- Status last verified
- Dec 2017
- First submitted
- 18 Mar 2015
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02392481
- Acronym / sponsor ID
- 352.2087
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 29 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Procedure: Biofluid sampling |
| Mild asthma | – | – |
| Moderate asthma | – | – |
| Severe asthma | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma and healthy subject
Key inclusion criteria (4 listed)
- 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).
- Further Inclusion criteria apply.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofluid sampling | Procedure or surgery | Healthy subjects |
Primary outcome
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.
2 secondary outcomes
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)
Time frame: 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)
Time frame: follow-up visit 28 days after baseline (Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Synopsis LinkLink provided by the sponsor.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Boehringer Ingelheim at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1) (time frame: Baseline (Visit 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.