RecruitingPhase 2ACTRN12612001167853

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


Sponsor

The Children's Hospital at Westmead

Enrollment

30 participants

Start Date

Nov 1, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding inhaled mannitol (a dry powder that helps loosen and clear mucus from the airways) as an extra therapy during a hospital admission for a lung infection flare-up improves outcomes for children with cystic fibrosis (CF). CF causes thick, sticky mucus to build up in the lungs, making infections more common and harder to treat. Researchers want to see whether adding mannitol to the standard intravenous antibiotic treatment helps children's lungs recover better and faster. You may be eligible if: - Your child is at least 6 years old and under 18 years of age - Your child has been admitted to hospital with a lung infection flare-up (pulmonary exacerbation) that requires intravenous antibiotics - Your child's lung function (FEV1) is at least 40% of predicted for their age You may NOT be eligible if: - Your child started oral steroids at admission or started a new mucus-clearing drug within 3 months of admission - Your child requires oxygen or is planned to have surgery during this admission - Your child has significant coughing of blood (haemoptysis) during the current flare-up Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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