Bronchoscopy Study for Severe Asthma
This study is not yet open for participant recruitment.
Verified October 2011 by University of Pennsylvania
Sponsor:
University of Pennsylvania
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
|
|
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:
|
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
- Subject is an adult male or female between 18 and 65 years of age inclusive.
- 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)
- 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.
- Subject's asthma has been stable for the past 30 days.
- The subject has been a non-smoker for the past year and should have less than a 10 pack year history.
- The subject must be capable of and willing to provide written informed consent
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
Healthy Subject Inclusion Criteria
- 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.
- Subject must have an exclusion of asthma or other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)
- The subject has been a non-smoker for the past year and should have less than a 10 pack year history.
- The subject has a negative methacholine test (PC20 > 16) and does not use inhaled steroids and/or SABA.
- The subject must be capable of and willing to provide written informed consent
The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
-
Exclusion Criteria:
- As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- 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.
- No oral steroids within the last 3 months.
- No current anticoagulant and/or antiplatelet therapy.
- The subject has a history of alcohol or drug abuse within the last 5 years.
- The subject has history of hepatitis B, hepatitis C, or HIV virus.
- The subject has a history of chemotherapy or radiotherapy within the last 2 years.
- The subject has a history of diabetes.
- 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 May 22, 2013