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

A double blind, placebo-controlled, randomised study of inhaled mannitol during acute pulmonary exacerbation in children with cystic fibrosis – a pilot study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001167853

Enrollment

Registered

2012-11-02

Start date

2007-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To see if the addition of dry powder mannitol as an extra therapy during hospitalisation for an acute pulmonary exacerbation in young people with Cystic Fibrosis improves outcomes from that admission. Our hypothesis is that it will improve not only clinical status at the time of discharge but also measures of lung function.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Healthy volunteers

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 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

Outcome results