Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— LAB-Card  

Official title:

Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872090
• Other study ID #: P/2015/255
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to quantify the possible deleterious effect on the cardiac autonomic nervous system control of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.

Description:

This is a cross-over study with randomization in terms of 4 treatments: two long-acting muscarinic antagonists (tiotropium and glycopyrronium), one long-acting beta-adrenoceptor agonist(indacaterol) and placebo. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with FEV1 / FVC <70%

Exclusion Criteria:

• beta blocker
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
inhalation
• Glycopyrronium
inhalation
• Tiotropium
inhalation
• Placebo

Procedure:
• photoplethysmography
inhalation

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-frequency (LF)/High-frequency (HF) ratio in supine position during a tilt table test after bronchodilators inhalation	For each patient, the LF/HF ratio after inhalation of an active drug (indacaterol or glycopyrronium or tiotropium) will be compared to LF / HF ratio measured after inhalation of a placebo.	10 minutes
Secondary	Slope of baroreflex in supine position	Drugs vs placebo	10 minutes
Secondary	LF / HF ratio derived from the spectral analysis of R-R intervals measured after verticalisation during a tilt table test	Drugs vs placebo	10 minutes
Secondary	Total spectral power during a tilt table tes	Drugs vs placebo	20 minutes
Secondary	Value of HF (gross value then normalized according to the average R-R interval) during a tilt table tes	Drugs vs placebo	20 minutes
Secondary	RMSSD (Root Mean Square of the Successive Differences) index during a tilt table test	Drugs vs placebo	20 minutes
Secondary	Variability in blood pressure during a tilt table test	Drugs vs placebo	20 minutes