Clinical trial NCT02487394: Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma
Official title: Protein Biomarker Discovery and Validation in COPD And Asthma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
COPD
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Exhaled Breath Condensate Protein Concentration
timeFrame: 1 year through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: UTMB
name: William Calhoun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: