Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00630812

Run by

Syntara

People needed

318

Starts

2008-09-01

Expected to finish

2010-11-01

Last updated by the study team

2020-10-09

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have given written informed consent to participate in this study in accordance with local regulations
• Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
• Be aged > 6 years old
• Have FEV1 >40 % and < 90% predicted
• Be able to perform all the techniques necessary to measure lung function

You may not qualify if…

• Investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
• Be considered "terminally ill" or eligible for lung transplantation
• Have had a lung transplant
• Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
• Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment
• Have had a myocardial infarction in the three months prior to enrolment
• Have had a cerebral vascular accident in the three months prior to enrolment
• Have had major ocular surgery in the three months prior to enrolment
• Have had major abdominal, chest or brain surgery in the three months prior to enrolment
• Have a known cerebral, aortic or abdominal aneurysm
• Be breast feeding or pregnant, or plan to become pregnant while in the study
• Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
• Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
• Have a known allergy to mannitol
• Be using beta blockers
• Have uncontrolled hypertension - systolic BP > 190 and / or diastolic BP > 100
• Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
• Be 'Mannitol Tolerance Test positive'

Where it is running

• Central Connecticut Cystic Fibrosis Center — Hartford, Connecticut, United States
• Nemours Childrens Clinic — Jacksonville, Florida, United States
• Batchelor Children's Research Institute - University of Miami — Miami, Florida, United States
• Nemours Children's Clinic Orlando — Orlando, Florida, United States
• St Lukes CF Center of Idaho — Idaho City, Idaho, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Maine Pediatric Specialty Group — Portland, Maine, United States
• John Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Missouri — Columbia, Missouri, United States
• Nebraska Medical Center - Nebraska Regional CF Center — Omaha, Nebraska, United States
• Women and Childrens Hospital of Buffalo — Buffalo, New York, United States
• The Toledo Hospital and Toledo Childrens Hospital — Toledo, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• St Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• Medical University of SC — Charleston, South Carolina, United States
• Sanford Children's Specialty Clinic — Sioux Falls, South Dakota, United States
• Le Bonheur Children's Medical Center — Memphis, Tennessee, United States
• Children's Chest Associates of Austin — Austin, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Alamo Clinical Research Associates — San Antonio, Texas, United States
• Christus Santa Rosa Children's Hospital Cystic Fibrosis Center — San Antonio, Texas, United States
• Pediatric Research, VCU Medical Centre — Richmond, Virginia, United States
• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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