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Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
NCT00630812 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00630812
The ClinicalTrials.gov registry entry for NCT00630812 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syntara, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00630812 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Florida, Arizona, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00630812?
The interventions under investigation include: Placebo comparator (DRUG), inhaled mannitol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00630812?
This trial is sponsored by Syntara, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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