A randomised, cross-over trial of upright sitting with or without positive expiratory pressure during nebulised delivery of medication to improve the pattern of aerosol deposition in participants with cystic fibrosis

Not Applicable

• Conditions: Cystic Fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12612000017820
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Inclusion Criteria: To participate in this study, a person must:
1be 18 years of age or older with confirmed cystic fibrosis on genetic or sweat testing
2be able to read, write and comprehend English
3have stable lung function
4be willing to inhale a 4mL radioaerosol and undergo a 20-minute gamma scan, on two occasions.

Exclusion Criteria

Exclusion Criteria: A person will be ineligible to participate in this study if s/he:
1has significant malignant, neurological or musculoskeletal conditions
2is unable to perform spirometry reproducibly
3is pregnant, or is sexually active and unwilling to use contraception during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The 3-dimensional map of the lung fields will be divided into unit volumes (voxels). The amount of radioactivity in each voxel will be calculated. The standard deviation of the radioactivity across all voxels within the margins of the lung fields will be used as an index of uniformity of the pattern of deposition for each participant.[Immediately post 20 minutes of inhalation]

Secondary Outcome Measures

Name	Time	Method
The ratio of central:peripheral deposition of radioactivity will be determined by the mean number of counts per voxel in the central lung field divided by the mean number of counts per voxel in peripheral the lung field.[Immediately post 20 minutes of inhalation];The ratio of apical:non-apical deposition of radioactivity will be determined by the mean number of counts per voxel in the apical one third of the lung field divided by the mean number of counts per voxel in the basal two thirds of the lung field.[Immediately post 20 minutes of inhalation];The deposition fraction will be calculated as the amount of radioactivity in the lung fields divided by the amount of radioactivity in the nebuliser before inhalation, with correction for decay.[Immediately post 20 minutes of inhalation]