Aerosol Particle Size and Breathing Pattern During Inhaled Furosemide

NCT04130815 | Unknown Phase 1

• 1 other identifier: L19185
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Slow/Deep/Large

ACTIVE COMPARATOR

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

Drug: Inhaled furosemide

Slow/Deep/Small

ACTIVE COMPARATOR

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.

Drug: Inhaled furosemide

Fast/Shallow/Large

ACTIVE COMPARATOR

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.

Drug: Inhaled furosemide

Fast/Shallow/Small

ACTIVE COMPARATOR

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.

Drug: Inhaled furosemide

Interventions

Inhaled furosemide DRUG

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

Also known as: Lasix

Fast/Shallow/Large; Fast/Shallow/Small; Slow/Deep/Large; Slow/Deep/Small

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy volunteers aged 18 and over

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford Brookes University: lead

Study Sites (1)

Oxford Brookes University

Oxford, Oxfordshire, OX3 0BP, United Kingdom

RECRUITING

Related 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.

  PMID: 30236110 BACKGROUND

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Central Study Contacts

Shakeeb H Moosavi, PhD

CONTACT

+44 (0)1865 483257; smoosavi@brookes.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which droplet size they will be receiving on any one test day
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Clinical Physiology

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 17, 2019
• Study Start: October 14, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)