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

Protein Biomarker Discovery and Validation in COPD And Asthma

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.

Study Overview

• Status: Terminated
• Conditions: Asthma; COPD
• Intervention / Treatment: Procedure: Exhaled Breath Condensate (EBC)

Detailed Description

There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). 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. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.

In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.

• Study Type: Observational
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• Criteria for Asthma

INCLUSION

• 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

INCLUSION

• 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

Exclusion Criteria:

• Exclusion for Asthma EXCLUSION

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Collection of EBC condensate
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); Collection of EBC condensate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Breath Condensate Protein Concentration	Protein concentrations were below the limit of detectability and are not scientifically robust.	1 year through study completion

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: William Calhoun, M.D., UTMB

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 13-0462