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

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Research question: To determine whether the addition of positive expiratory pressure (PEP) improves uniformity of deposition of an inhaled aerosol in upright sitting in participants with cystic fibrosis. Methods: Inclusion criteria: greater than or equal to 18 years of age, confirmed cystic fibrosis, stable lung function. Participants will inhale a 4mL radioaerosol in two stategies in random order throughout the nebulisation period of 20 minutes: 1. Standard nebulisation period of 20 minutes, or 2. Nebulisation period of 20 minutes with the addition of a PEP device. After each nebulisation a gamma camera will perform a 20-minute deposition scan incorporating a transmission scan to outline the three-dimensional margin of the lung fields. This data will be reconstructed to determine the distribution of the deposited radioaerosol in the lungs. A 15% improvement in uniformity of deposition is the proposed minimum difference that would make further investigation of the PEP strategy worthwhile in patient populations. Significance of project: In many patient populations (eg, cystic fibrosis, HIV and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. The ability to deliver a drug more uniformly to the lung using the addition of PEP may have a significant impact on treatment efficacy for people with lung disease. Data from healthy participants will aid interpretation of subsequent studies in patients.

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