Sample Collection in Smoking Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Respivert Ltd
• Investigators: Study Director: Dr Garth Rapeport, Respivert Ltd

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ENA002