Status:
COMPLETED
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Lead Sponsor:
Syntara
Collaborating Sponsors:
ethica Clinical Research Inc.
Europe: KasaConsult bvba, Hoegaarden, Belgium
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief 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 fu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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'
- \-
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00630812
Start Date
September 1 2008
End Date
November 1 2010
Last Update
October 9 2020
Active Locations (53)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Central Connecticut Cystic Fibrosis Center
Hartford, Connecticut, United States, 66106
3
Nemours Childrens Clinic
Jacksonville, Florida, United States, 32207
4
Batchelor Children's Research Institute - University of Miami
Miami, Florida, United States, 33136