Not Yet RecruitingPhase 3ACTRN12619001032145

Effect of nebulised furosemide on breathlessness and cough in interstitial lung disease: a pilot study


Sponsor

Hunter New England Health

Enrollment

12 participants

Start Date

Aug 5, 2019

Study Type

Interventional

Conditions

Summary

This pilot randomised crossover study will seek to recruit volunteers with interstitial lung disease experiencing significant cough and dyspnoea. These volunteers will be administered nebulised furosemide in the context of exercise induced dyspnoea, with nebulised normal saline being used as a control. The response of the participants’ cough and dyspnoea to the administration of these agents will be recorded and compared. It is our hypothesis that the administration of nebulised furosemide will symptomatically improve the cough and dyspnoea experienced.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

  • Age > 18 years
  • Confirmed physician diagnosis of an interstitial lung disease
  • Medical research council dyspnoea scale of 3-5
  • Cough visual analogue scale >4cm
  • FVC >=30% predicted
  • DLCO >=20% predicted

Exclusion Criteria15

  • Current smoker
  • Clinical history of asthma or vocal cord dysfunction
  • Currently pregnant or breastfeeding
  • Any clinically significant cardiopulmonary abnormalities not related to ILD, including features of congestive cardiac failure on examination or history suggestive of uncontrolled ischaemic heart disease.
  • Any clinically significant neurological, renal, endocrine, gastrointestinal, hepatic or haematological abnormalities uncontrolled with standard treatment
  • History of psychiatric, medical or surgical disorders that may interfere with study
  • Clinical history suggestive of respiratory infection in month preceding study
  • Alcohol or recreational drug abuse
  • Inability to understand directions for study assessment, including inability to comprehend English language.
  • Inability to complete questionnaires required for the study, including visual analogue scales.
  • Inability to be contacted in case of emergency
  • Participation in another study at the same time or within a prior 3-month period
  • Regular use of short or long-acting opioids, pregabalin or gabapentin.
  • Inability to complete a 6 minute walk test
  • Allergy or significant adverse reaction to furosemide

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Interventions

This pilot study will seek to recruit volunteers with interstitial lung disease (ILD) experiencing significant cough and dyspnoea. These volunteers will be administered a single dose of nebulised furo

This pilot study will seek to recruit volunteers with interstitial lung disease (ILD) experiencing significant cough and dyspnoea. These volunteers will be administered a single dose of nebulised furosemide (80mg) in the context of exercise induced dyspnoea, with a dose of nebulised normal saline of equivalent milliliters being used as a control. The order of the administration of these nebulised agents will be randomised, and both participants and researchers will be blinded to nebulised agent order. The nebulised agents will be administered by a study doctor (these are medical registrars, advanced trainees in respiratory medicine or respiratory specialists) immediately prior to exercise, i.e. exercise testing will commence immediately after completion of nebulised agent administration. This will take place in either the outpatient clinic or respiratory function testing laboratory of the John Hunter Hospital. The exercise testing referred to is the 6 minute walk test (6MWT). The 6MWT is a exercise testing tool developed by the American thoracic society, which is used both clinically and in research to assess functional exercise capacity. As the name implies, the test assesses the distance which a participant can walk over a 6 minute period. The second nebulised agent will be given a minimum of 3 days after the first to allow a sufficient wash out period. The response of the participants’ cough and dyspnoea to the administration of both nebulised furosemide and normal saline will be recorded and compared.


Locations(1)

John Hunter Hospital - New Lambton

NSW, Australia

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