Aerosol Particle Size and Breathing Pattern During Inhaled Furosemide

Healthy Volunteers Clinical Trial

— FurAH-II  

Official title:

Effect of Aerosol Particle Size and Breathing Pattern of Inhalation on Relief of Experimentally Induced Air Hunger by Inhaled Furosemide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04130815
• Other study ID #: L19185
• Status: Recruiting
• Phase: Phase 1
• Start date: October 14, 2019
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: Oxford Brookes University
• Contact: Shakeeb H Moosavi, PhD
• Phone: +44 (0)1865 483257
• Email: smoosavi[@]brookes.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Respiratory Aspiration

Intervention

Drug:
• Inhaled furosemide
4ml of 10mg/ml solution of furosemide nebulized with small and large droplet sizes and inhaled with different breathing patterns

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes University	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale for air hunger	The visual analogue scale (VAS) is from 0 (no air hunger) to 100 (extreme air hunger -tolerable limit). The VAS ratings are taken every 15 seconds during each experimentally induced air hunger test. Each breathing test (hypercapnia with constrained ventilation) is performed before and after each mist inhalation. The final minute of a 5 minute steady state period of hypercapnia and constrained ventilation is analysed during each breathing test (8 breathing tests in total)	Final minute of a 5 minute steady state period per breathing test