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Completed Phase 3 Interventional Results available

Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

ClinicalTrials.gov ID: NCT00630812

Public ClinicalTrials.gov record NCT00630812. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 10:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00630812
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Syntara
Industry
Enrollment
318 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2008 (Type not available)
Primary completion
Apr 2010 (Actual)
Completion
Nov 2010 (Actual)
Last update posted
Oct 9, 2020

2008 – 2010

United States locations

U.S. sites
28
U.S. states
22
U.S. cities
26
Facility City State ZIP Site status
University of Arizona Tucson Arizona 85724 —
Central Connecticut Cystic Fibrosis Center Hartford Connecticut 66106 —
Nemours Childrens Clinic Jacksonville Florida 32207 —
Batchelor Children's Research Institute - University of Miami Miami Florida 33136 —
Nemours Children's Clinic Orlando Orlando Florida 32801 —
St Lukes CF Center of Idaho Idaho City Idaho 83712 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Louisiana State University Health Sciences Center Shreveport Louisiana 71130-3932 —
Maine Pediatric Specialty Group Portland Maine 4102 —
John Hopkins Baltimore Maryland 21287 —
Massachusetts General Hospital Boston Massachusetts 62114 —
University of Missouri Columbia Missouri 65212 —
Nebraska Medical Center - Nebraska Regional CF Center Omaha Nebraska 68198-5300 —
Women and Childrens Hospital of Buffalo Buffalo New York 14222 —
The Toledo Hospital and Toledo Childrens Hospital Toledo Ohio 43606 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
St Christopher's Hospital for Children Philadelphia Pennsylvania 19134 —
Medical University of SC Charleston South Carolina 29425 —
Sanford Children's Specialty Clinic Sioux Falls South Dakota 57117 —
Le Bonheur Children's Medical Center Memphis Tennessee 38105 —
Children's Chest Associates of Austin Austin Texas 78723 —
Baylor College of Medicine Houston Texas 77030 —
Alamo Clinical Research Associates San Antonio Texas 78212 —
Christus Santa Rosa Children's Hospital Cystic Fibrosis Center San Antonio Texas 78229-3900 —
Pediatric Research, VCU Medical Centre Richmond Virginia 23298 —
Virginia Commonwealth University Richmond Virginia 23298 —
University of Washington medical centre Seattle Washington 58103 —
University of Wisconsin Madison Wisconsin 53972 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00630812, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 9, 2020 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00630812 live on ClinicalTrials.gov.

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