None listed
Conditions
Brief summary
Research question: To determine whether alternate side lying improves uniformity of deposition of an inhaled aerosol compared to upright sitting in participants with cystic fibrosis (CF). Methods: Inclusion criteria: greater than or equal to 18 years of age, confirmed CF, stable lung function. Participants will inhale a 4mL radioaerosol in two positions in random order throughout the nebulisation period of 20 minutes: 1. Upright sitting: or 2. Alternate Side Lying: (alternated between left and right at each minute) After each nebulisation a gamma camera will perform a 20 minute deposition scan incorporating a 2 minute 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 the alternate side lying strategy worthwhile in CF patient populations. Significance of project: In many patient populations (for example, cystic fibrosis, HIV, asthma and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. Typically the upper lobes receive a reduced dose compared to the rest of the lung. The ability to deliver a drug more uniformly to the lung using the simple strategy of side lying may have a significant impact on treatment efficacy, acceptability and compliance for people with lung disease.
Interventions
Participants will inhale 4mL technetium-99m DTPA radioaerosol in two positions in random order throughout the nebulisation period of 20 minutes for each of the positioning regimens on two separte days: 1. Upright sitting: or 2. Alternate Side Lying: (alternated between left and right at each minute) The two study days will have a minimum of 48 hours washout between them and not greater than 7 days (to ensure clinical stability). After each nebulisation a gamma camera will perform a 20 minute deposition scan incorporating a 2 minute 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 the alternate side lying strategy worthwhile in CF patient populations.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion Criteria: To participate in this study, a person must: 1 be 18 years of age or older 2 be able to read, write and comprehend English 3 have cystic fibrosis, diagnosed by sweat test or genotyping 4 have an FEV1 within 10% of the best recorded value as an outpatient during the previous 6 months 5 be willing to inhale a 4mL radioaerosol and undergo a 20min gamma scan, on two occasions.
Exclusion criteria
Exclusion Criteria: A person will be ineligible to participate in this study if s/he: 1 has significant malignant, neurological or musculoskeletal comorbidity, according to clinic records 2 has hepatomegaly, hepatosplenomegaly, or intestinal obstruction, according to clinic records 3 is unable to perform spirometry reproducibly 4 is pregnant, or is sexually active and unwilling to use contraception during the study.