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NCT00669331 · ClinicalTrials.gov registry record · Phase 3
Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
A Phase 3 study, sponsored by Syntara.
- Completed
- Registry status
- Phase 3
- Development phase
- 485
- Enrollment target
NCT00669331 is a Phase 3 study that has completed, run by Syntara. The registered enrollment target is 485 participants.
The verdict
NCT00669331, a Phase 3 study, has completed, sponsored by Syntara.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 485 participants
- Enrollment target
Study Summary
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis. The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis. We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health. Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against control.
Interventions
- DRUG Inhaled mannitol
- DRUG Matched control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00669331
The ClinicalTrials.gov registry entry for NCT00669331 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 485 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syntara, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Inhaled mannitol is the first listed.
NCT00669331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00669331 about?
NCT00669331 is a clinical study titled "Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis". No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been ...
What is the current status of trial NCT00669331?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2009-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00669331?
The interventions under investigation include: Inhaled mannitol (DRUG), Matched control (DRUG).
Who is sponsoring clinical trial NCT00669331?
This trial is sponsored by Syntara, which has 5 total clinical trials registered on ClinicalTrials.gov.
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