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NCT00630812 · ClinicalTrials.gov registry record · Phase 3
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
A Phase 3 study of Cystic Fibrosis, sponsored by Syntara.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
- 20
- Study locations
NCT00630812: Completed Phase 3 study of Cystic Fibrosis, sponsored by Syntara.
NCT00630812 is a Phase 3 study of Cystic Fibrosis that has completed, run by Syntara. The registered enrollment target is 318 participants, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630812, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Syntara.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.
Primary Outcome
Change from baseline in forced expiratory volume at one second (FEV1) averaged over 26 weeks (measured at 6,14 and 26 weeks) 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.
Conditions Studied
Interventions
- DRUG Placebo comparator
- DRUG inhaled mannitol
Study Locations (20)
Florida
- Nemours Childrens Clinic - Jacksonville
- Batchelor Children's Research Institute - University of Miami - Miami
- Nemours Children's Clinic Orlando - Orlando
Arizona
- University of Arizona - Tucson
Connecticut
- Central Connecticut Cystic Fibrosis Center - Hartford
Idaho
- St Lukes CF Center of Idaho - Idaho City
Illinois
- Northwestern Memorial Hospital - Chicago
Louisiana
- Louisiana State University Health Sciences Center - Shreveport
Maine
- Maine Pediatric Specialty Group - Portland
Maryland
- John Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00630812 record still lists
NCT00630812 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (80% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo comparator is the first listed.
NCT00630812 names 20 study sites across 18 states, led by Florida, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00630812 about?
NCT00630812 is a clinical study titled "Long Term Administration of Inhaled Mannitol in Cystic Fibrosis". The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and qu...
What is the current status of trial NCT00630812?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2008-09. Estimated completion is 2010-11.
What conditions does trial NCT00630812 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00630812?
The interventions under investigation include: Placebo comparator (DRUG), inhaled mannitol (DRUG).
Who is sponsoring clinical trial NCT00630812?
This trial is sponsored by Syntara, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00630812 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00630812's enrollment target sits among peer trials
318 20th of 169 higher than 150 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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