CFDB - Cystic Fibrosis DataBase

ongoing trials trial from other registries

A study examining the utility of inhaled mannitol as an additional therapy during an admission to hospital for an acute pulmonary exacerbation in children with cystic fibrosis - Not known

Study design (if review, criteria of inclusion for studies)

Recruiting. Last update November 2012 - Randomised controlled trial. Parallel

Participants

Inclusion criteria: admission to hospital with a pulmonary exacerbation as defined by the Fuch’s Criteria and requiring IV antibiotic treatment; at least 6 years of age (max 18); FEV1 at least 40% predicted. Exclusion criteria: commencement of oral steroids (on admission) or new mucolytic (within 3 months of admission); oxygen requirement or planned surgery during admission; significant haemoptysis during current exacerbation

Interventions

Inhaled dry powder mannitol 400mg (10 x 40mg capsules) twice daily for 12 days as an adjunctive treatment during hospitalisation for an acute pulmonary exacerbation. Capsules were placed in a special delivery device which pierced the capsule and the contents were inhaled.

Outcome measures

Primary Outcome: improvement in clinical status at the end of the treatment period (as assessed using a CF specific clinical score)

Keywords: Child; Adolescent; Inhalation OR nebulised; Mannitol; pharmacological_intervention; placebo; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Respiratory System Agents; Exacerbation; Respiratory Tract Infections; Infection; Bacterial Infections; Respiratory Tract Diseases;