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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: Completed Phase 3 study, sponsored by Syntara.
NCT02134353 is a Phase 3 study that has completed, run by Syntara. The registered enrollment target is 423 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The mean absolute change from baseline FEV1 (mL) over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits. Missing values due to withdrawal for reasons related to safety or efficacy were imputed using a baseline observation carried forward approach (BOCF).
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 |
What the finished NCT02134353 record still lists
NCT02134353 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Inhaled mannitol is the first listed.
NCT02134353 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02134353's enrollment target sits among peer trials
423 885th of 2000 higher than 1,115 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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