At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
mannitol +2 moredrug
Likely dose
mannitol 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating mannitol, mannitol + pulmozyme, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 20 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2005
Enrollment StartNov 2005
Primary CompletionFeb 2008
TodayJul 2026
First PostedJul 4, 2005
Enrollment StartNov 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 21.0 years ago
Interventions
mannitoldrug
400mg BD for 12 weeks
mannitol + pulmozymedrug
combination
Dornase alphadrug
2.5mg daily for 2 weeks