Status:
COMPLETED
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Lead Sponsor:
Syntara
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvem...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- Confirmed diagnosis of cystic fibrosis
- Aged \> 6 years
- FEV1 \>30 % and \< 90% predicted
- Able to perform all the techniques necessary to measure lung function
- Main
Exclusion
- "Terminally ill" or listed for lung transplantation
- Had a lung transplant
- Using nebulised hypertonic saline
- Significant episode of haemoptysis (\>60 mL) in the three months prior to enrolment
- Recent myocardial infarction or cerebral vascular accident
- Breast feeding or pregnant, or plan to become pregnant while in the study participating in another investigative drug study, parallel to, or within 4 weeks of study entry
- Allergy or intolerance to mannitol
- Using beta blockers
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00446680
Start Date
March 1 2007
End Date
May 1 2010
Last Update
June 25 2010
Active Locations (29)
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1
Childrens Hospital at Westmead
Sydney, New South Wales, Australia, 2145
2
Sydney Childrens Hospital
Sydney, New South Wales, Australia
3
Royal Brisbane Children's Hospital
Brisbane, Queensland, Australia, 4029
4
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032