An observational study in Asthma and COPD, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by The University of Texas Medical Branch, Galveston · Observational
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.
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.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 9 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Inclusion Criteria:
INCLUSION
INCLUSION
Exclusion Criteria:
Exclusion for Asthma EXCLUSION
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.
Procedure: Exhaled Breath Condensate (EBC)
Non-Smokers Subjects with no active smoking. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.
Procedure: Exhaled Breath Condensate (EBC)
Collection of EBC condensate
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
| Milestone | Asthma Subjects-Non-Smokers | COPD Subjects-Smokers |
|---|---|---|
| Started | 8 | 1 |
| Completed | 8 | 0 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Asthma Subjects-Non-Smokers | COPD Subjects-Smokers |
|---|---|---|
| Started | 4 | 0 |
| Completed | 4 | 0 |
| Not completed | 0 | 0 |
Protein concentrations were below the limit of detectability and are not scientifically robust.
| ug/ml | COPD, Smokers | Asthma, Non-Smokers |
|---|---|---|
| Exhaled Breath Condensate Protein Concentration | NA ± 0 | NA ± 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asthma, Non-Smokers | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| COPD, Smokers | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
The overall participants was a total of 9.
| Age, Categorical(Participants) | Asthma, Non-Smokers | COPD, Smokers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 1 | 9 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Asthma, Non-Smokers | COPD, Smokers | Total |
|---|---|---|---|
| Female | 6 | 0 | 6 |
| Male | 2 | 1 | 3 |
| Region of Enrollment(participants) | Asthma, Non-Smokers | COPD, Smokers | Total |
|---|---|---|---|
| United States | 8 | 1 | 9 |
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston