Overview

This trial has been terminated.

Conditions asthma, copd
Treatments asthma, smokers and non-smokers, copd, smokers and non-smokers
Sponsor The University of Texas Medical Branch, Galveston
Start date May 2014
End date January 2016
Trial size 12 participants
Trial identifier NCT02487394, 13-0462

Summary

The purpose of the study is to better understand the function of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, our propose is to use discovery proteins and techniques to identify protein expression signatures. In Phase II, is to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
In Phase I, One arm will contain subjects who are active smokers and the other arm will contain subjects with no active smoking. 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.
asthma, smokers and non-smokers
Comparing protein expressions between the two groups.
copd, smokers and non-smokers
We will validate the prdictive value of the proteomic signatures for therapeutic responses.
(Active Comparator)
For Phase II, Phase II will again be divided into two arms based on active smoking status as discussed previously.
asthma, smokers and non-smokers
Comparing protein expressions between the two groups.
copd, smokers and non-smokers
We will validate the prdictive value of the proteomic signatures for therapeutic responses.

Primary Outcomes

Measure
Protein Biomarkers
time frame: 4 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Protein Biomarker Discovery and Validation in COPD And Asthma
Principal investigator William Calhoun, M.D.
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 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. 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. 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). The investigators will not recruit Stage IV COPD due to the heightened risk of bronchoscopy in these patients. In the second Phase, is to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, the investigators will recruit a total of 80 subjects that will include subjects who are continuing in the study from Phase I. Patients continuing from Phase I will wait 4-6 weeks from bronchoscopy before starting Phase II. This will be done in order to avoid having the prior bronchoscopy affecting the Phase II results. Phase II will again be divided into two arms based on active smoking status as discussed previously. Each arm will contain 40 subjects, 20 with COPD (Stage II and III with 10 subjects in each) along with 20 asthmatics (Mild to Moderate disease with 10 subjects in each).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston.