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NCT00233051 · ClinicalTrials.gov registry record · NA
Evaluating Genes in Sputum to Measure Drug Response in COPD
A NA study, sponsored by National Jewish Health.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT00233051: Clinical Trial NA study, sponsored by National Jewish Health.
NCT00233051 is a NA study that was terminated before completion, run by National Jewish Health. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00233051, a NA study, was terminated before completion, sponsored by National Jewish Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD. We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.
Interventions
- DRUG Salmeterol or Salmeterol/Fluticasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-04 |
| Est. Completion | 2006-06 |
| Phase | NA |
Why NCT00233051 stopped before completion
NCT00233051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Salmeterol or Salmeterol/Fluticasone is the first listed.
NCT00233051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00233051 about?
NCT00233051 is a clinical study titled "Evaluating Genes in Sputum to Measure Drug Response in COPD". The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD. We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with m...
What is the current status of trial NCT00233051?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2003-04. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00233051?
The interventions under investigation include: Salmeterol or Salmeterol/Fluticasone (DRUG).
Who is sponsoring clinical trial NCT00233051?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00233051's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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