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Aerosol Inhalation Treatment for Dyspnea

18. maj 2017 opdateret af: Robert Banzett, Beth Israel Deaconess Medical Center
The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Unstable heart or circulation disease
  • Stroke
  • Seizure disorder
  • Severe migraine headaches
  • Liver or kidney disease
  • Adrenal gland problem (Pheochromocytoma)
  • Nerve problems that may affect your breathing sensation
  • Brain cancer
  • Drug or alcohol problem
  • Systemic lupus erythematosis (SLE)
  • High levels of depression, panic disorder, or other significant mental health problems
  • Serious ongoing pain
  • Pregnant
  • Under 18 years old
  • Not Fluent in English

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: F(40), then Saline, then IV.F

On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
Medicin: Saltvand
Medicin: Furosemid
Andre navne:
  • Lasix
Eksperimentel: IV.F, then F(40), then Saline

On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.
Medicin: Saltvand
Medicin: Furosemid
Andre navne:
  • Lasix
Eksperimentel: Saline, then F(40), then IV.F

On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 3), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.
Medicin: Saltvand
Medicin: Furosemid
Andre navne:
  • Lasix
Eksperimentel: F(80), then Saline, then Saline

On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
Medicin: Saltvand
Medicin: Furosemid
Andre navne:
  • Lasix
Eksperimentel: Saline, then F(80), then Saline

On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.
Medicin: Saltvand
Medicin: Furosemid
Andre navne:
  • Lasix
Eksperimentel: Saline, then Saline, then F(80)

On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.

On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.
Medicin: Saltvand
Medicin: Furosemid
Andre navne:
  • Lasix

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subject Rating of Breathing Discomfort (Dyspnea)
Tidsramme: The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.
Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale. The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea. The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.
The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Multidimensional Dyspnea Profile
Tidsramme: Measured before intervention
Characterization of subject's response to laboratory dyspnea model. Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis. Subjects were asked to complete the MDP with reference to the last 30 sec of each run. To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale. The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.
Measured before intervention
Urine Output
Tidsramme: Cumulative urine output 1 hour after intervention
Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment
Cumulative urine output 1 hour after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beth Israel Deaconess Medical Center

Samarbejdspartnere

National Institute of Nursing Research (NINR)

Efterforskere

  • Ledende efterforsker: Robert B Banzett, PhD, Beth Israel Deaconess Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2011

Primær færdiggørelse (Faktiske)

1. april 2016

Studieafslutning (Faktiske)

1. april 2017

Datoer for studieregistrering

Først indsendt

23. september 2011

Først indsendt, der opfyldte QC-kriterier

26. september 2011

Først opslået (Skøn)

27. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-P-000027/1
  • R01NR012009 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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