Bronchoscopy Study for Severe Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:7/11/2015
Start Date:January 2013
End Date:December 2014
Contact:WIlliam Russell, RPFT
Phone:215-662-9250

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An Exploratory Study to Obtain Functional and Transcriptional/Translational Profiling of Cells From Bronchial Lavages and Brushings in Severe Asthmatics and Healthy Control Subjects

The purpose of this research study is to collect lung tissue and fluid from two groups of
people: those who have severe asthma, and those who do not. These samples will then be
tested in a laboratory to identify differences in the lung tissue cells and fluids that may
exist between these two groups of people.


Inclusion Criteria:

- Asthma Subject Inclusion Criteria

1. Subject is an adult male or female between 18 and 65 years of age inclusive.

2. Subject must have a pre-history of a physician's diagnosis of severe asthma
(according to GINA classification) with some reversible airway obstruction
(shown by peak flow or FEV1 in the last 12 months with a change of 12% in the
absolute FEV1 measurement) and an exclusion of other significant pulmonary
diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and
bronchopulmonary dysplasia)

3. Subject has a positive methacholine test (PC20 < 16). This test sometimes cannot
be performed in severe asthmatics because of low baseline FEV1 (< FEV1 50%).
SABA reversibility of FEV1 is sufficient to define asthma in absence of MCh
PC20.

4. Subject's asthma has been stable for the past 30 days.

5. The subject has been a non-smoker for the past year and should have less than a
10 pack year history.

6. The subject must be capable of and willing to provide written informed consent

7. The subject is able to understand and comply with protocol requirements and
timetables, instructions and protocol-stated restrictions.

- Healthy Subject Inclusion Criteria

1. Subject is an adult male or female between 18 and 65 years of age inclusive.
(Subjects will be age and gender matched) With age matching, we will enroll in a
manner that age and gender will be matched 1:1 in the following cohorts: age
21-30, 31-40, 41-50, 51-60, 61-65.

2. Subject must have an exclusion of asthma or other significant pulmonary diseases
(i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and
bronchopulmonary dysplasia)

3. The subject has been a non-smoker for the past year and should have less than a
10 pack year history.

4. The subject has a negative methacholine test (PC20 > 16) and does not use
inhaled steroids and/or SABA.

5. The subject must be capable of and willing to provide written informed consent

6. The subject is able to understand and comply with protocol requirements and
timetables, instructions and protocol-stated restrictions.

-

Exclusion Criteria:

1. As a result of the medical interview, physical examination or screening
investigations, the physician responsible considers the volunteer unfit for the
study.

2. The subject has received an investigational drug or participated in any other
research trial within 30 days or 5 half-lives, or twice the duration of the
biological effect of any drug (whichever is longer), prior to the current study.

3. No oral steroids within the last 3 months.

4. No current anticoagulant and/or antiplatelet therapy.

5. The subject has a history of alcohol or drug abuse within the last 5 years.

6. The subject has history of hepatitis B, hepatitis C, or HIV virus.

7. The subject has a history of chemotherapy or radiotherapy within the last 2
years.

8. The subject has a history of diabetes.

9. The subject is pregnant or lactating.
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