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NCT01832220 · ClinicalTrials.gov registry record
Genomic Research in Alpha-1 Antitrypsin Deficiency
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 140
- Enrollment target
NCT01832220: Completed study, sponsored by University of Pittsburgh.
NCT01832220 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 140 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832220 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 140 participants
- Enrollment target
Study Summary
This project is designed to examine the interaction between the microflora in the lower airway and the concentration of a serum protein called alpha-1 antitrypsin. The hypothesis is that alpha-1 antitrypsin impacts the diversity and content of the lower airway microflora, resulting in a less inflammatory airway. The Specific Aims are: 1. To compare the lower respiratory tract microbiome and virome population diversity and content in age and GOLD stage matched PiZZ individuals not receiving augmentation therapy, PiZZ individuals on augmentation therapy, PiMZ individuals not receiving augmentation therapy, and PiMM individuals with chronic obstructive pulmonary disease (COPD). 2. Determine correlations between bronchoalveolar lavage (BAL) and peripheral blood gene expression patterns and patterns in lung microbial and viral populations across all cohorts. 3. Correlate the presence or absence of computed tomography (CT) bronchiectasis and bronchiolectasis with patterns in the microbiome population diversity and content. 4. To identify and define novel molecular phenotypes of Alpha-1 Antitrypsin Deficiency (AATD) based on computational integration of clinical, transcriptomic, and microbiome data.
Primary Outcome
Presenting characteristics (e.g., sex) will be compared among those with and without augmentation therapy using the appropriate test for continuous (e.g., t-test, Wilcoxon) or discrete (e.g., chi-square) data. Paired t-test will be used to compare the diversity, as measured by the number of microbes, and McNemar's test will be used to compare the lower respiratory tract (LRT) microbiome and virome, assessed by the presence or absence of specific organisms (e.g., viral, gram negative bacteria). C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-09 |
What the finished NCT01832220 record still lists
NCT01832220 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01832220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832220 about?
NCT01832220 is a clinical study titled "Genomic Research in Alpha-1 Antitrypsin Deficiency". This project is designed to examine the interaction between the microflora in the lower airway and the concentration of a serum protein called alpha-1 antitrypsin. The hypothesis is that alpha-1 antitrypsin impacts the diversity and content of the lower airway microflora, resulting in a less inflamm...
What is the current status of trial NCT01832220?
This trial is currently completed. The enrollment target is 140 participants. The study started on 2013-05. Estimated completion is 2015-09.
Who is sponsoring clinical trial NCT01832220?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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