Aerosol Inhalation Treatment for Dyspnea
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
Outros nomes:
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|
Experimental: 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. |
Outros nomes:
|
|
Experimental: 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. |
Outros nomes:
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|
Experimental: 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. |
Outros nomes:
|
|
Experimental: 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. |
Outros nomes:
|
|
Experimental: 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. |
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Subject Rating of Breathing Discomfort (Dyspnea)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Multidimensional Dyspnea Profile
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert B Banzett, PhD, Beth Israel Deaconess Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Distúrbios Respiratórios
- Sinais e Sintomas Respiratórios
- Dispnéia
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Natriuréticos
- Moduladores de transporte de membrana
- Diuréticos
- Inibidores simportadores de cloreto de sódio e potássio
- Furosemida
Outros números de identificação do estudo
- 2011-P-000027/1
- R01NR012009 (Concessão/Contrato do NIH dos EUA)
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