Specificity of Dyspnoea Relief With Inhaled Furosemide

NCT02881866 | Completed Phase 1

• 1 other identifier: UREC150939
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of inhaled furosemide on different types of breathlessness relief in healthy volunteers. Each volunteer inhaled mists of either furosemide or a control substance on 3 occasions per day on 2 separate days. On one day they performed one breathlessness test which creates an 'urge to breathe' known as air hunger (AH) and the other day they performed a breathlessness test which increases the sense of work/effort (WE) of breathing. The study is double blinded so neither the volunteer or the research knows which mist is being inhaled.

Conditions

Dyspnea

Keywords

Air hunger; Work/effort; Aerosolized; Hypercapnia; Resistive load; Nebulised

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale for breathlessness type

  The visual analogue scale (VAS) is from 0 (no breathlessness) to 100 (maximal breathlessness willing to tolerate). The VAS is measure every 15-20 seconds during each experimentally induced breathing test. Each breathing test is performed before and after each mist inhalation. Total of 6 breathing tests. The final minute of a 4 minute steady state breathing test is analysed.

  20minutes

Study Arms (2)

Air Hunger

ACTIVE COMPARATOR

Previous studies have shown that inhaled furosemide relieves 'air hunger'. Each volunteer has 3 mists per visit. The mists are either in the order of Furosemide-Saline-Furosemide or Saline-Furosemide-Saline. The furosemide mist is 40mg (10mg/ml) nebulised and the saline mist is 4ml nebulised. Induced air hunger (hypercapnia with constrained ventilation) is the active comparator and will be the type of breathlessness induced, before and after each mist inhalation on one day. .

Drug: Furosemide; Drug: Saline

Work Effort

EXPERIMENTAL

Induced sense of breathing effort (raised ventilation with external resistive load) is the 'experimental arm' and will be the type of breathlessness induced, before and after each mist inhalation on the other day. .

Drug: Furosemide; Drug: Saline

Interventions

Furosemide DRUG

Also known as: Lasix

Air Hunger; Work Effort

Saline DRUG

Also known as: 0.9% sodium chloride

Air Hunger; Work Effort

Eligibility Criteria

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

You may qualify if:

• \- Healthy individuals

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

Location

Related Publications (3)

• Moosavi SH, Binks AP, Lansing RW, Topulos GP, Banzett RB, Schwartzstein RM. Effect of inhaled furosemide on air hunger induced in healthy humans. Respir Physiol Neurobiol. 2007 Apr 16;156(1):1-8. doi: 10.1016/j.resp.2006.07.004. Epub 2006 Aug 28.

  PMID: 16935035 BACKGROUND

• Nishino T, Ide T, Sudo T, Sato J. Inhaled furosemide greatly alleviates the sensation of experimentally induced dyspnea. Am J Respir Crit Care Med. 2000 Jun;161(6):1963-7. doi: 10.1164/ajrccm.161.6.9910009.

  PMID: 10852774 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Dyspnea; Hypercapnia

Interventions

Furosemide; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Joanna C Grogono, MBBS

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)