Asthma, COPD
Conditions
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.
Interventions
PROCEDUREExhaled Breath Condensate (EBC)
Collection of EBC condensate
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Breath Condensate Protein Concentration | 1 year through study completion | Protein concentrations were below the limit of detectability and are not scientifically robust. |
Countries
United States
Participant flow
Pre-assignment details
Anticipated to enroll both smoking and non-smoking asthma subjects. Anticipated to enroll both smoking and non-smoking COPD subjects. NO smoking asthmatic subjects enrolled. NO non-smoking COPD subjects enrolled. There are only two groups.
Participants by arm
| Arm | Count |
|---|---|
| Asthma, Non-Smokers No active smoking defined as never smoking or having stopped smoking for 5 years or greater. | 8 |
| COPD, 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. | 1 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Asthma, Non-Smokers | COPD, Smokers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 1 Participants | 9 Participants |
| Region of Enrollment United States | 8 participants | 1 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 1 |
| other Total, other adverse events | 0 / 8 | 0 / 1 |
| serious Total, serious adverse events | 0 / 8 | 0 / 1 |
Outcome results
Primary
Exhaled Breath Condensate Protein Concentration
Protein concentrations were below the limit of detectability and are not scientifically robust.
Time frame: 1 year through study completion
Population: An observational Study principally for collecting biological samples.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| COPD, Smokers | Exhaled Breath Condensate Protein Concentration | NA ug/ml | Standard Deviation 0 |
| Asthma, Non-Smokers | Exhaled Breath Condensate Protein Concentration | NA ug/ml | Standard Deviation 0 |