Sample Collection in Smoking Asthma

Asthma Clinical Trial

Official title:

A Sample Collection Protocol for Disease Profiling of Smoking Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676467
• Other study ID #: ENA002
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: January 7, 2013
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Respivert Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 ß-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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Respivert Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum and serum biomarkers	Measurement of biomarkers of inflammation, including but not limited to: TNFa, IL-8, IFN?, IP10 and eotaxin in sputum supernatant and serum will be collected and measured only once, at Visit 2 (Day 10).	Day 10	No
Primary	Sputum cell count	Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).	Day 10	No