Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma

NCT02487394 | Terminated Results DMC

• 1 other identifier: 13-0462
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.

Conditions

Asthma; COPD

Outcome Measures

Primary Outcomes (1)

• Exhaled Breath Condensate Protein Concentration

  Protein concentrations were below the limit of detectability and are not scientifically robust.

  1 year through study completion

Study Arms (2)

COPD Smoker Subjects

Smokers Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study.

Procedure: Exhaled Breath Condensate (EBC)

Asthma Non-Smoker Subjects

Non-Smokers Subjects with no active smoking. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.

Procedure: Exhaled Breath Condensate (EBC)

Interventions

Exhaled Breath Condensate (EBC) PROCEDURE

Collection of EBC condensate

Asthma Non-Smoker Subjects; COPD Smoker Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be divided into two identical arms based on smoking status. One arm will contain subjects who are active smokers and the other arm will contain subjects with no active smoking. Each arm will contain 50 subjects, 26 with COPD (Stage II and III with 13 subjects in each) along with 24 asthmatics (Mild to Moderate disease with 12 subjects in each).

You may qualify if:

• Criteria for Asthma
• History consistent with asthma: episodic wheezing, shortness of breath, or cough
• Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age \>18yrs
• FEV1 \>40% predicted
• Never smoker, current smoker, or quit smoking ≥5 years ago Criteria for COPD
• History consistent with COPD: dyspnea with exertion, productive cough, progressive course
• Smoking history of at least 20 pack years
• Current smoker or quit smoking ≥5 years ago
• Age \>18yrs
• FEV1: Forced Vital Capacity (FVC) ratio \< 0.70 following 2 puffs of albuterol
• FEV1 greater than 50% predicted

You may not qualify if:

• Other respiratory illness other than asthma
• Chronic infectious process
• Significant other medical illness
• Inability to consent
• Other respiratory illness other than COPD
• Chronic infectious process
• Significant other medical illness
• Inability to consent
• Pregnancy

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

It was anticipated to enroll in 4 arms of the study, only 2 arms had successful enrollment.

Results Point of Contact

• Title: William Calhoun, M.D.
• Organization: UTMB

wjcalhou@utmb.edu

409-772-1176

Study Officials

• William Calhoun, M.D.

  UTMB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: July 1, 2015
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-04

Locations

US (1)