AsthmaNCT01676467
Sample Collection in Smoking Asthma
An observational study of Asthma, run by Respivert Ltd at 1 site in United Kingdom.
Trial summary
This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers and normal healthy subjects, to compare the biological markers of disease and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be selected by advertisements from the general population and primary care.
Who may be able to join
- Male or female, between 18 and 55 years of age, inclusive.
- no clinically significant abnormalities.
- able to produce an adequate induced sputum sample.
- no history of chronic respiratory disease including asthma.
- no history of allergic symptoms e.g., allergic rhinitis, eczema.
- No other acute illness in the 6 weeks prior to Visit 1.
Show all 19Show fewer
- Additional Inclusion Criterion for Healthy Smoking Subjects
- Be a smoker for >/= 1 year.
- Additional Inclusion Criteria (Persistent Asthmatic Subjects):
- No contraindications to the procedures in this study.
- Symptoms compatible with asthma for at least 6 months prior to screening
- Pre-bronchodilator FEV1 >/=50% predicted at Visit 1.
- clinically stable asthma for at least 6 weeks prior to Visit 1.
- No acute illness including asthma exacerbation requiring augmentation of therapy in the 6 weeks prior to Visit 1.
- on current asthma controller therapy for >/= 6 weeks prior to Visit 1.
- Additional Inclusion for Steroid Naïve Asthmatics (smoking or non-smoking)
- Must not have received a regular course of inhaled or oral corticosteroids for at least 3 months prior to Visit 1.
- Additional Inclusion for Smoking Asthmatics
- Be a smoker for >/= 1 year prior to Visit 1.
Who cannot join
- History of any clinically significant medical illness or medical disorders.
- Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.
- bronchodilator response of >/=12% and at least 200 mL from baseline or an FEV1 value <85% of predicted value at Visit 1.
- positive urine pregnancy screening result.
- recent history (within previous 6 months) of alcohol or drug abuse.
- Positive urine toxicology screen for substances of abuse
Show all 21Show fewer
- positive serology test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at Visit 1.
- Received an experimental antibody or biologic therapy within the 6 months prior to Visit 1, or received any other experimental therapy or new investigational agent within 60 days of Visit 1.
- Is an employee or family member of the investigator, study centre or Sponsor.
- Any condition that, in the opinion of the investigator, would complicate or compromise the study, or the well-being of the subject.
- Use of any antioxidants within 1 week of Visit 1 and throughout the study period.
- known allergies, hypersensitivity, or intolerance to short acting β-agonists (SABA).
- Additional Exclusion Criterion for Healthy Non-smoking Subjects
- subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to Visit 1.
- Additional Exclusion Criteria (Persistent Asthma Subjects):
- Diagnosis of allergic bronchopulmonary aspergillosis (ABPA), allergic bronchopulmonary mycosis (ABPM), or occupational asthma.
- Diagnosis of COPD, cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.
- Use of theophylline, N-acetyl cysteine, or any other anti-oxidants within 1 week of Visit 1 and throughout the study period.
- positive test for tuberculosis at Visit 1.
- Additional Exclusion Criterion for Non-smoking Asthmatic Subjects
- subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sample Collection Protocol for Disease Profiling of Smoking Asthma.
This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers and normal healthy subjects, to compare the biological markers of disease and inflammation.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smoking asthma on steroids | Smokers with persistent asthma on background steroid therapy | |
| Smoking asthma steroid naïve | Smokers with persistent asthma, steroid naive | |
| asthma on steroids | Non-Smokers with persistent asthma on background steroid therapy | |
| asthma, steroid naïve | Non-smokers with persistent asthma, steroid naive | |
| Healthy smoking | Healthy smoking control subjects | |
| Healthy non-smoking | Healthy non-smoking control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum and serum biomarkers
Measurement of biomarkers of inflammation, including but not limited to: TNFα, IL-8, IFNγ, IP10 and eotaxin in sputum supernatant and serum will be collected and measured only once, at Visit 2 (Day 10).
Measured: Day 10
Sputum cell count
Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Garth Rapeport, Study director, Respivert Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676467
- Sponsor's protocol ID
- ENA002
- Status last verified
- Jan 2013
- First submitted
- 21 Aug 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sample Collection Protocol for Disease Profiling of Smoking Asthma.
- ClinicalTrials.gov ID
- NCT01676467
- Acronym / sponsor ID
- ENA002
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers and normal healthy subjects, to compare the biological markers of disease and inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Smoking asthma on steroids | – | –Smokers with persistent asthma on background steroid therapy |
| Smoking asthma steroid naïve | – | –Smokers with persistent asthma, steroid naive |
| asthma on steroids | – | –Non-Smokers with persistent asthma on background steroid therapy |
| asthma, steroid naïve | – | –Non-smokers with persistent asthma, steroid naive |
| Healthy smoking | – | –Healthy smoking control subjects |
| Healthy non-smoking | – | –Healthy non-smoking control subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be selected by advertisements from the general population and primary care.
Key inclusion criteria (19 listed)
- Male or female, between 18 and 55 years of age, inclusive.
- no clinically significant abnormalities.
- able to produce an adequate induced sputum sample.
- no history of chronic respiratory disease including asthma.
- no history of allergic symptoms e.g., allergic rhinitis, eczema.
Key exclusion criteria (21 listed)
- History of any clinically significant medical illness or medical disorders.
- Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.
- bronchodilator response of >/=12% and at least 200 mL from baseline or an FEV1 value <85% of predicted value at Visit 1.
- positive urine pregnancy screening result.
- recent history (within previous 6 months) of alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sputum and serum biomarkers
Time frame: Day 10
Measurement of biomarkers of inflammation, including but not limited to: TNFα, IL-8, IFNγ, IP10 and eotaxin in sputum supernatant and serum will be collected and measured only once, at Visit 2 (Day 10).
Sputum cell count
Time frame: Day 10
Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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.
Dr Garth Rapeport study director
Respivert Ltd
1 site 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 Respivert Ltd at 1 site 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 19 inclusion and 21 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sputum and serum biomarkers (time frame: Day 10). 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 8 Jan 2013.