Clinical trial NCT01745809: Bronchoscopy Study for Severe Asthma
Official title: An Exploratory Study to Obtain Functional and Transcriptional/Translational Profiling of Cells From Bronchial Lavages and Brushings in Severe Asthmatics and Healthy Control Subjects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Severe Persistent Asthma
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2012-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 severe asthma subjects matched with 10 healthy control subjects

Brief summary: 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.


Eligibility criteria: 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.

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     Exclusion Criteria:

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  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.

Primary outcomes:
measure: To obtain bronchial brushings and bronchial alveolar lavage fluid from 10 subjects with severe asthma (GINA criteria in The Global Initiative for Asthma, http://www.ginasthma.org ) and from 10 matched normal healthy subjects.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Airways Biology Initiative at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Reynold Panettieri, MD
role: PRINCIPAL_INVESTIGATOR
References: