Bronchoscopy Study for Severe Asthma

This study is not yet open for participant recruitment.
Verified October 2011 by University of Pennsylvania
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01745809
First received: December 6, 2012
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Severe Persistent Asthma
Procedure: Bronchoscopy

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Severe Asthmatics
Subjects with a pre-existing physician diagnosis of asthma with reversible airflow obstruction of at least 12%.
Procedure: Bronchoscopy
Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.
Other Names:
  • Fiberoptic Bronchoscopy
  • Bronchoalveolar Lavage
Healthy non-smokers
Subjects will be never smokers or former smokers for the past year and less than 10 pack years lifetime with no history of asthma or any other lung disease.
Procedure: Bronchoscopy
Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.
Other Names:
  • Fiberoptic Bronchoscopy
  • Bronchoalveolar Lavage

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

10 severe asthma subjects matched with 10 healthy control subjects

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.

      -

      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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745809

Contacts
Contact: WIlliam Russell, RPFT 215-662-9250
Contact: Danielle Frame McComb, PA-C 215-662-9250

Locations
United States, Pennsylvania
Airways Biology Initiative at the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Reynold A Panettieri, MD         
Sponsors and Collaborators
University of Pennsylvania
Centocor, Inc.
Investigators
Principal Investigator: Reynold Panettieri, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01745809     History of Changes
Other Study ID Numbers: 814383
Study First Received: December 6, 2012
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

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 April 23, 2014