Clinical trial NCT01676467: Sample Collection in Smoking Asthma
Official title: A Sample Collection Protocol for Disease Profiling of Smoking Asthma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Respivert Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected by advertisements from the general population and primary care.

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.


Eligibility 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.

Primary outcomes:
measure: Sputum and serum biomarkers
timeFrame: Day 10
measure: Sputum cell count
timeFrame: Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
state: Middlesex
Study officials:
affiliation: Respivert Ltd
name: Dr Garth Rapeport
role: STUDY_DIRECTOR
References: