Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

Launched by SYNTARA · Feb 27, 2008

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Have given written informed consent to participate in this study in accordance with local regulations
• • 2. 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)
• • 3. Be aged \> 6 years old
• • 4. Have FEV1 \>40 % and \< 90% predicted
• • 5. Be able to perform all the techniques necessary to measure lung function
• Exclusion Criteria:
• • 1. 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.
• • 2. Be considered "terminally ill" or eligible for lung transplantation
• • 3. Have had a lung transplant
• • 4. Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
• • 5. Have had a significant episode of hemoptysis (\>60 mL) in the three months prior to enrolment
• • 6. Have had a myocardial infarction in the three months prior to enrolment
• • 7. Have had a cerebral vascular accident in the three months prior to enrolment
• • 8. Have had major ocular surgery in the three months prior to enrolment
• • 9. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
• • 10. Have a known cerebral, aortic or abdominal aneurysm
• • 11. Be breast feeding or pregnant, or plan to become pregnant while in the study
• • 12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
• • 13. Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
• • 14. Have a known allergy to mannitol
• • 15. Be using beta blockers
• • 16. Have uncontrolled hypertension - systolic BP \> 190 and / or diastolic BP \> 100
• • 17. 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
• • 18. Be 'Mannitol Tolerance Test positive'
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