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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02593344 |
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Date of registration:
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16/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Peripheral Endothelial Function in Asthmatic Patients
Endothasthm |
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Scientific title:
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Peripheral Endothelial Function in Asthmatic Patients |
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Date of first enrolment:
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December 13, 2012 |
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Target sample size:
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113 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02593344 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe Devillier, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Foch hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients must have a clear-cut history of asthma at the time of enrolment into the
trial (eventually confirmed in the past and documented by an increased
hyperresponsiveness to methacholine; or a bronchodilator reversibility to a
beta-2-adrenergic drug).
Exclusion Criteria:
- Patients with unstable asthma
- Patients with a significant acute disease other than asthma. A significant disease is
defined as a disease which, in the opinion of the investigator, may influence the
results of the trial.
- Pregnant or nursing women.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Endothelial Function
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Intervention(s)
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Device: Endopat
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Primary Outcome(s)
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measure of reactive hyperemia-peripheral artery tone index
[Time Frame: day 1]
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Secondary Outcome(s)
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measure of the forced expiratory flow in one second (FEV1)
[Time Frame: day 1]
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measure of the forced vital capacity (FVC)
[Time Frame: day 1]
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measure of expiratory flow between 25% and 75% (FEF25-75%)
[Time Frame: day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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