Sample Collection in Smoking Asthma
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Purpose
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.
| Condition |
|---|
|
Asthma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | A Sample Collection Protocol for Disease Profiling of Smoking Asthma. |
- Sputum and serum biomarkers [ Time Frame: Day 10 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).
Biospecimen Retention: Samples With DNA
serum sputum
| Enrollment: | 23 |
| Study Start Date: | September 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects will be selected by advertisements from the general population and primary care.
Inclusion Criteria (healthy subjects):
- 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.
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.
Exclusion Criteria (healthy):
- 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
- 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Respivert Ltd |
| ClinicalTrials.gov Identifier: | NCT01676467 History of Changes |
| Other Study ID Numbers: | ENA002 |
| Study First Received: | August 21, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013