Specificity of Dyspnoea Relief With Inhaled Furosemide (FurosAH)

August 24, 2016 updated by: Joanna Grogono, Oxford Brookes University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, placebo-controlled trial. 16 healthy volunteers will attend 4 sessions. After 2 practice sessions subjects will undergo 2 test days where they will be made to feel 'air hunger' (hypercapnia with constrained ventilation) before and after mist inhalations on one day and sense of breathing 'effort' (raised ventilation with external resistive load) before and after mist inhalations on the second test day. The mist will either be furosemide or a placebo (saline) mist.

The urge to urinate from systemic absorption from the lungs will be accounted for by a concomitant administration of intravenous furosemide when saline is inhaled.

Furosemide is a prescription drug which makes kidneys produce more urine. When administered by inhalation as an aerosol it has direct action in the lungs which sensitises slowly adapting stretch receptors which is believed to account for the relief of dyspnoea previously reported with inhaled furosemide.

Vagal afferents from the pulmonary stretch receptors are known to be involved in relief of air hunger but it is not known if they will also relieve the sense of breathing effort. Relief of breathlessness will be measured and compared between the two trial days to see if furosemide specifically relieves the 'air hunger' type of breathlessness and not the 'effort' type of breathlessness.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 0BP
        • Oxford Brookes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Healthy individuals

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Air Hunger

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: Saline
Other Names:
  • 0.9% sodium chloride
Drug: Furosemide
Other Names:
  • Lasix
Experimental: Work Effort
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: Saline
Other Names:
  • 0.9% sodium chloride
Drug: Furosemide
Other Names:
  • Lasix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale for breathlessness type
Time Frame: 20minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford Brookes University

Investigators

  • Principal Investigator: Joanna C Grogono, MBBS, Oxford Brookes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC150939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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