Evaluation of the Lungs of Individuals With Lung Disease

Completed

• Conditions: Bronchitis; Asthma; Lung Disease; Emphysema; COPD
• Interventions: Procedure: Lung Disease

• Registration Number: NCT00224198
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this protocol is to obtain biologic materials from the blood and lungs from patients with lung disease in order to develop an understanding of the etiology and pathogenesis of these disorders. General admission criteria for this project will require at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-ray consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) patients with diseases of organs with known association with lung disease.

Detailed Description

Patients will undergo a general medical evaluation by a pulmonary physician (and consultants as appropriate for other organs). The typical routine medical studies to be carried out may include: chest X-ray (posterior-anterior and lateral), non-contrast high resolution CT scan of the chest, pulmonary function tests, electrocardiogram, echocardiogram, general hematologic studies, general serologic studies, /immunologic studies, biochemical analyses (including carboxyhemoglobin to measure blood carbon monoxide levels in order to accurately evaluate the diffusion capacity in individuals who smoke since smoking increases the blood levels of carbon monoxide), alcohol blood test, urinalysis, urine chemistries (including blood or urine nicotine and cotinine test to evaluate urine for active or passive exposure to nicotine), blood or urine drug screening (to evaluate use of recreational drugs and/or mood altering medications), pregnancy test (if applicable) and HIV serology. Also, a sweat chloride and sweat rate test may be performed by the physician to evaluate participants with a possible diagnosis of cystic fibrosis.

The study individual will undergo fiberoptic bronchoscopy with a combination of bronchial brushing and/or bronchoalveolar lavage and/or bronchial wall biopsy. The primary factor for determining if an individual will have bronchial alveolar lavages (BAL) and/or brushings and/or biopsies is the particular lung disease affecting the individual. This will depend on the known mechanism relevant to the pathogenesis of the particular disease. For example, in individuals with asthma, the samples may include airway brushing and airway biopsies; in contrast, in individuals with chronic obstructive pulmonary disease (COPD), sampling may include airway brushings, airway biopsies, and bronchoalveolar lavage. Other determining factors include: the amount of moderate sedation (if used) and the amount of analgesia used; the maximal dosage of topical lidocaine that is allowed per procedure; allergic reactions to any of the medications used in the procedures; and individual's tolerance to the procedure.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Must provide informed consent
• Males and females, age 18 years and older
• Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease
• Must provide HIV informed consent

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Exclusion Criteria

• Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study
• Drug and/or alcohol abuse within the past six months
• Females who are pregnant or nursing
• Individuals who test positive for HIV (other than for studies directly related to the HIV virus)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Disease	Lung Disease	All study individuals will be males or females that are 18 years or older and are able to provide informed consent and have been diagnosed with lung disease.

Primary Outcome Measures

Name	Time	Method
Understand lung disease etiology and pathogenesis	9/31/2012	The primary objective is to develop and understand the etiology and pathogenesis of these lung disease disorders.

Secondary Outcome Measures

Name	Time	Method
Identify suitable candidates	9/31/2012	The secondary objective is to identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs.

Trial Locations

Locations (1)

Department of Genetic Medicine, Weill Cornell Medical College; 🇺🇸 New York, New York, United States