Clinical trial NCT04130815: Aerosol Particle Size and Breathing Pattern During Inhaled Furosemide
Official title: Effect of Aerosol Particle Size and Breathing Pattern of Inhalation on Relief of Experimentally Induced Air Hunger by Inhaled Furosemide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Furosemide will be inhaled on 4 separate days each with a different pattern of breathing/droplet size combination. The four combinations will be: (i) slow/deep breathing with small droplet size, (ii) slow/deep breathing with large droplet size, (iii) fast/shallow breathing with large droplet size and (iv) fast/shallow breathing with small droplet size.
Primary purpose: BASIC_SCIENCE

Brief summary: The study hypothesises that the variability in relief of air hunger with inhaled furosemide that is reported in previous studies can be explained by the breathing pattern adopted during the inhalation and the droplet size in the aerosol, both of which would influence the site of deposition of the aerosol in the lungs

Detailed description: Recent studies suggest that inhaling furosemide as a mist reduces air hunger in healthy volunteers in whom air hunger is induced experimentally in the lab. However, how much reduction varies among individuals. It is not known if the way the mist is breathed (slow/deep or fast/shallow) or the size of the droplets in the mist (large or small) can explain the variation in relief. Both of these factors can influence the site of deposition of the aerosol in the lungs

In this study the relief of air hunger (induced by hypercapnia and constrained ventilation) will be compared when furosemide is inhaled quickly or slowly, and when the mist has large or small droplets. 20 healthy volunteers will be recruited. After a practice session, the 'air hunger' test will be performed before and after 4ml of a 10mg/ml solution of furosemide (40mg). This will be repeated on 4 separate test days using a different method of inhaling the furosemide on each day.

Eligibility criteria: Inclusion Criteria:

- Healthy volunteers aged 18 and over

Exclusion Criteria:

* On any medication, including herbal medication (other than mild analgesics, vitamins and mineral supplements or, for females, oral contraceptives), whether prescribed or over-the-counter, in the two weeks prior to test sessions involving administration of furosemide or saline.
* Female participants who are pregnant, lactating or planning pregnancy over the course of trial
* A medical history of heart, kidney or liver disease/electrolyte disturbances/ immunosuppression/frequent fainting episodes/COPD/nasal polyps/Addison's/acute porphyria/significant prostatic symptoms/acute gout attack/life expectancy \<6months or history of allergic reaction to furosemide and/or any of the other ingredients of furosemide or amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Have participated in another research trial involving an investigational product in the past 4 weeks.

Primary outcomes:
measure: Visual analogue scale for air hunger
timeFrame: Final minute of a 5 minute steady state period per breathing test
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
References:
citation: Grogono JC, Butler C, Izadi H, Moosavi SH. Inhaled furosemide for relief of air hunger versus sense of breathing effort: a randomized controlled trial. Respir Res. 2018 Sep 20;19(1):181. doi: 10.1186/s12931-018-0886-9.