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

Asthma Clinical Trial

— Proteomics  

Official title:

Protein Biomarker Discovery and Validation in COPD And Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02487394
• Other study ID #: 13-0462
• Status: Terminated
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: April 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Procedure:
• Exhaled Breath Condensate (EBC)
Collection of EBC condensate

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled Breath Condensate Protein Concentration	Protein concentrations were below the limit of detectability and are not scientifically robust.	1 year through study completion