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A randomised, cross-over trial of upright sitting versus alternate side lying during nebulised delivery of medication to improve the pattern of aerosol deposition in healthy participants

A randomised, cross-over trial of upright sitting versus alternate side lying during nebulised delivery of medication to improve the pattern of aerosol deposition in healthy participants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000674932
Acronym
Nil
Enrollment
13
Registered
2011-07-04
Start date
2009-04-20
Completion date
2009-06-25
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

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 further investigation of the alternate side lying 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. 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 a strategy of side lying 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.

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 dep

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.

Sponsors

Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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 normal lung function, with greater than or equal to 80% predicted FEV1 4 be 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: 1 has any respiratory condition 2 has significant malignant, neurological or musculoskeletal conditions 3 is unable to perform spirometry reproducibly 4 is pregnant, or is sexually active and unwilling to use contraception during the study 5 is in a dependent relationship to any of the investigators, eg. student, junior staff.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026