Bronchoscopy Study for Severe Asthma

NCT01745809 | Withdrawn DMC

• 1 other identifier: 814383
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Severe Asthmatics

Subjects with a pre-existing physician diagnosis of asthma with reversible airflow obstruction of at least 12%.

Procedure: Bronchoscopy

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

Interventions

Bronchoscopy PROCEDURE

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.

Also known as: Fiberoptic Bronchoscopy, Bronchoalveolar Lavage

Healthy non-smokers; Severe Asthmatics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 severe asthma subjects matched with 10 healthy control subjects

You may qualify if:

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

You may not qualify if:

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• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Centocor, Inc.: collaborator

Study Sites (1)

Airways Biology Initiative at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Bronchoscopy; Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Therapeutic Irrigation; Investigative Techniques

Study Officials

• Reynold Panettieri, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 1, 2015

Record last verified: 2011-10

Locations

US (1)