Status:
COMPLETED
Mannitol Dose Response Study in Cystic Fibrosis
Lead Sponsor:
Syntara
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
7+ years
Phase:
PHASE2
Brief Summary
Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of muc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of cystic fibrosis (sweat test/genotype)
- 7 years or older
- FEV1 between 40% and 90% of predicted for height, age and gender.
- Able to perform acceptable-quality spirometry
- Clinically stable in the week up to study entry
- No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)
- Exclusion Criteria
- Currently active asthma
- Subjects colonized with Burkholderia cepacia or MRSA
- Considered "terminally ill" or listed for transplantation
- Requiring home oxygen or assisted ventilation
- Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)
- Significant episode of haemoptysis (\>60 mLs) in the previous 12 months
- Heart attack or stroke in last 3 months
- Known aortic or cerebral aneurysm
- Subjects who are breast feeding or pregnant.
- At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
- Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
- Known intolerance to mannitol or unable to take any form of bronchodilator medications.
- Uncontrolled hypertension, systolic BP \> 200 or diastolic BP\> than 100
- Concurrent use of beta blocker medication
- Concurrent use of hypertonic saline
- Canada:
- Concurrent use of other pharmacological mucolytic agents other than Pulmozyme
- Argentina:
- Concurrent use of other pharmacological mucolytic agents including Pulmozyme
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00251056
Start Date
October 1 2005
End Date
August 1 2008
Last Update
August 29 2008
Active Locations (12)
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1
Hospital de Niños Superiora Sor María Ludovica
La Plata, Buenos Aires, Argentina, B1904CSI
2
Hospital Pediatrico
Resistencia, Chaco Province, Argentina
3
Hospital Interzonal Especializado Materno Infantil (HIEMI)
Buenos Aires, Argentina
4
Hospital General de Niños
CABA, Argentina