Sample Collection in Smoking Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Respivert Ltd
ClinicalTrials.gov Identifier:
NCT01676467
First received: August 21, 2012
Last updated: January 7, 2013
Last verified: January 2013
  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.

Resource links provided by NLM:


Further study details as provided by Respivert Ltd:

Primary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676467

Locations
United Kingdom
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Respivert Ltd
Investigators
Study Director: Dr Garth Rapeport Respivert Ltd
  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 September 30, 2014