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NCT02134353 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
A Phase 3 study, sponsored by Syntara.
- Completed
- Registry status
- Phase 3
- Development phase
- 423
- Enrollment target
NCT02134353 is a Phase 3 study that has completed, run by Syntara. The registered enrollment target is 423 participants.
The verdict
NCT02134353, a Phase 3 study, has completed, sponsored by Syntara.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 423 participants
- Enrollment target
Study Summary
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population
Interventions
- DRUG Inhaled mannitol
- DRUG Placebo Comparator: Arm B - Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2014-09 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02134353
The ClinicalTrials.gov registry entry for NCT02134353 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 423 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.
NCT02134353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02134353 about?
NCT02134353 is a clinical study titled "A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects". This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in...
What is the current status of trial NCT02134353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 423 participants. The study started on 2014-09. Estimated completion is 2017-02.
What interventions are being tested in trial NCT02134353?
The interventions under investigation include: Inhaled mannitol (DRUG), Placebo Comparator: Arm B - Control (DRUG).
Who is sponsoring clinical trial NCT02134353?
This trial is sponsored by Syntara, which has 5 total clinical trials registered on ClinicalTrials.gov.
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