Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT02872090
Last Updated: 2021-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2016-03-31
2021-06-01
Brief Summary
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Detailed Description
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Each subject will pass 4 experimental random sessions, separated by at least 48 hours given the pharmacokinetic properties of the drugs tested. During each of the 4 sessions, blood pressure will be measured. Drugs inhaled by the patient will be prepared and administered by the nurse according to the randomization schedule. Patients and investigators will be blinded regarding the administered drug/placebo (anonymized inhaler). After 15 minutes (at rest, at neutral temperature), patients will have continuous measurement of blood pressure and heart rate (by a sphygmomanometer) (1) in supine position and (2) after a passive tilt test on a tilt test table.
A flow-volume loop (BDV) will be performed after the tilt table test (measurement of Forced expiratory volume in 1 second (FEV1) and FVC).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
Indacaterol
inhalation
Glycopyrronium
inhalation
Tiotropium
inhalation
Placebo
photoplethysmography
inhalation
Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
Indacaterol
inhalation
Glycopyrronium
inhalation
Tiotropium
inhalation
Placebo
photoplethysmography
inhalation
Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
Indacaterol
inhalation
Glycopyrronium
inhalation
Tiotropium
inhalation
Placebo
photoplethysmography
inhalation
Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
Indacaterol
inhalation
Glycopyrronium
inhalation
Tiotropium
inhalation
Placebo
photoplethysmography
inhalation
Interventions
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Indacaterol
inhalation
Glycopyrronium
inhalation
Tiotropium
inhalation
Placebo
photoplethysmography
inhalation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* supraventricular rhythm disorder
* previous history of respiratory disease other than COPD
* diabetes
* autonomic dysfunction
* dysautonomia
* renal failure
* long-term oxygen therapy
* history of psychiatric illness
50 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Matthieu VEIL-PICARD
Role: PRINCIPAL_INVESTIGATOR
CHU Besançon
Locations
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Centre Hospitalier Régional Universitaire
Besançon, , France
Countries
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Other Identifiers
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P/2015/255
Identifier Type: -
Identifier Source: org_study_id
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