Aerosol Particle Size and Breathing Pattern During Inhaled Furosemide

NCT ID: NCT04130815

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2020-09-30

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Slow/Deep/Large

Slow/deep breathing pattern will be targeted while inhaling furosemide with nebulizer set to deliver 4ml of a 10mg/ml solution of furosemide with large droplet size over a 10-15 minute duration

Group Type: ACTIVE_COMPARATOR

Inhaled furosemide

Intervention Type: DRUG

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

Slow/Deep/Small

Slow/deep breathing pattern will be targeted while inhaling furosemide with nebulizer set to deliver 4ml of a 10mg/ml solution of furosemide with small droplet size over a 10-15 minute duration.

Group Type: ACTIVE_COMPARATOR

Inhaled furosemide

Intervention Type: DRUG

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

Fast/Shallow/Large

Fast/shallow breathing pattern will be targeted while inhaling furosemide with nebulizer set to deliver 4ml of a 10mg/ml solution of furosemide with large droplet size over a 10-15 minute duration.

Group Type: ACTIVE_COMPARATOR

Inhaled furosemide

Intervention Type: DRUG

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

Fast/Shallow/Small

Fast/shallow breathing pattern will be targeted while inhaling furosemide with nebulizer set to deliver 4ml of a 10mg/ml solution of furosemide with small droplet size over a 10-15 minute duration.

Group Type: ACTIVE_COMPARATOR

Inhaled furosemide

Intervention Type: DRUG

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

Interventions

Inhaled furosemide

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

Intervention Type: DRUG

Other Intervention Names

Lasix

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oxford Brookes University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shakeeb H Moosavi

Senior Lecturer in Clinical Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oxford Brookes University

Oxford, Oxfordshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Shakeeb H Moosavi, PhD

Role: CONTACT

smoosavi@brookes.ac.uk

+44 (0)1865 483257 ext. 3257

Facility Contacts

Shakeeb H Moosavi, PhD

Role: primary

smoosavi@brookes.ac.uk

+44 (0)1865 4823257 ext. 3257

References

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.

Reference Type: BACKGROUND

PMID: 30236110 (View on PubMed)

Other Identifiers

L19185

Identifier Type: -

Identifier Source: org_study_id