- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02141633
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment (smoker3)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.
Exclusion Criteria:
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women
- Cardiovascular disease and/or use of cardiovascular medications
- Subjects with known beta-adrenergic agonist intolerance
- A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)
- Acute respiratory infection within four weeks prior to the study
- Use of any airway medication
- Abnormal pulmonary function
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: smokers
participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
|
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Andre navne:
participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)
participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
|
Eksperimentel: non-smokers
healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
|
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Airway Blood Flow
Tidsramme: before and 15 minutes after albuterol inhalation
|
compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers
|
before and 15 minutes after albuterol inhalation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Echocardiogram
Tidsramme: MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
|
to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers
|
MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Anti-inflammatoriske midler
- Adrenerge agonister
- Dermatologiske midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Reproduktive kontrolmidler
- Anti-allergiske midler
- Adrenerge beta-2-receptoragonister
- Adrenerge beta-agonister
- Tokolytiske midler
- Fluticason
- Xhance
- Albuterol
Andre undersøgelses-id-numre
- 20120896
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