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

NCT ID: NCT02487394

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Asthma; COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Exhaled Breath Condensate (EBC)

Intervention Type: PROCEDURE

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.

Exhaled Breath Condensate (EBC)

Intervention Type: PROCEDURE

Collection of EBC condensate

Interventions

Exhaled Breath Condensate (EBC)

Collection of EBC condensate

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Calhoun, M.D.

Role: PRINCIPAL_INVESTIGATOR

UTMB

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

13-0462

Identifier Type: -

Identifier Source: org_study_id