Sample Collection in Smoking Asthma

NCT01676467 | Completed

• 1 other identifier: ENA002
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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).

  Day 10

• Sputum cell count

  Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).

  Day 10

Study Arms (6)

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 Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected by advertisements from the general population and primary care.

You may qualify if:

• 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.
• Be a smoker for \>/= 1 year.
• 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.
• Must not have received a regular course of inhaled or oral corticosteroids for at least 3 months prior to Visit 1.
• Be a smoker for \>/= 1 year prior to Visit 1.

You may not qualify if:

• 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).
• subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to Visit 1.
• 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.

Sponsors & Collaborators

• Respivert Ltd: lead

Study Sites (1)

Unknown Facility

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum 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

Study Officials

• Dr Garth Rapeport

  Respivert Ltd

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 31, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

GB (1)