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- Klinische proef NCT01440764
Aerosol Inhalation Treatment for Dyspnea
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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. |
Andere namen:
|
Experimenteel: 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. |
Andere namen:
|
Experimenteel: 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. |
Andere namen:
|
Experimenteel: 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. |
Andere namen:
|
Experimenteel: 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. |
Andere namen:
|
Experimenteel: 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. |
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Subject Rating of Breathing Discomfort (Dyspnea)
Tijdsspanne: 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.
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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.
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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.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Multidimensional Dyspnea Profile
Tijdsspanne: Measured before intervention
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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.
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Measured before intervention
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Urine Output
Tijdsspanne: Cumulative urine output 1 hour after intervention
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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
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Cumulative urine output 1 hour after intervention
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Robert B Banzett, PhD, Beth Israel Deaconess Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2011-P-000027/1
- R01NR012009 (Subsidie/contract van de Amerikaanse NIH)
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