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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 participants with cystic fibrosis

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 participants with cystic fibrosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000672954
Acronym
Nil
Enrollment
13
Registered
2011-07-04
Start date
2009-04-20
Completion date
Unknown
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

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 d

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

Royal Prince Alfred Hospital Sydney
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
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026