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NCT01616160 · ClinicalTrials.gov registry record · Phase 4
An Open-label Study to Identify Molecular Markers of Steroid Resistance
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT01616160: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01616160 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01616160, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Aim 1: To assess steroid sensitivity to mometasone furoate (MF) in cultured nasal polyp explant tissue in vitro. Aim 2: To assess steroid sensitivity in vivo in each subject by comparing symptom scores, nasal endoscopic findings before and following 4 weeks of treatment with mometasone furoate nasal spray (MFNS) and by comparing tissue immunohistology in NP biopsies pre- and post-treatment withA MFNS. Aim 3: To characterize the molecular signature of gene mRNA expression in "steroid-sensitive" and "steroid-resistant" NP using microarray on NP tissue pre- and post-MFNS treatment. Hypothesis 1: Genes that regulate apoptosis are dysregulated in nasal polyp (NP) inflammatory cells, epithelial cells and smooth muscle actin myofibroblasts leading to persistence of inflammatory cell infiltration and abnormal epithelial and myofibroblast cellular proliferation. These can be corrected by mometasone. Apoptosis-regulating genes that cannot be corrected by mometasone are upregulated in steroid-resistant NP. Elucidation of this dysregulation may prove insightful in understanding the mechanism of action of mometasone in NP and identifying potential molecular targets that will increase steroid sensitivity or, conversely, overcome steroid resistance. Hypothesis 2: There is a molecular signature of gene expression in NP that signifies steroid sensitive NP (SS-NP). This signature is altered in steroid resistant NP (SR-NP). Elucidation of differences in the molecular signature of SS-NP versus SR-NP before and after treatment with mometasone furoate (MFNS) will provide novel insight into treatment of NP with steroids.
Interventions
- DRUG mometasone furoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-01-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01616160
The ClinicalTrials.gov registry entry for NCT01616160 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which mometasone furoate is the first listed.
NCT01616160 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01616160 about?
NCT01616160 is a clinical study titled "An Open-label Study to Identify Molecular Markers of Steroid Resistance". Aim 1: To assess steroid sensitivity to mometasone furoate (MF) in cultured nasal polyp explant tissue in vitro. Aim 2: To assess steroid sensitivity in vivo in each subject by comparing symptom scores, nasal endoscopic findings before and following 4 weeks of treatment with mometasone furoate nasa...
What is the current status of trial NCT01616160?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2013-07. Estimated completion is 2018-01-09.
What interventions are being tested in trial NCT01616160?
The interventions under investigation include: mometasone furoate (DRUG).
Who is sponsoring clinical trial NCT01616160?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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