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

Centre Hospitalier Universitaire de Besancon

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Tiotropium; Procedure: photoplethysmography; Drug: Glycopyrronium; Drug: Placebo; Drug: Indacaterol

Study type: Interventional

Funder types: Other

Identifiers

NCT02872090

P/2015/255

Details and patient eligibility

About

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.

Full 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).

Enrollment: 42 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 4 patient groups

Arm 1

Experimental group

Description:

The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo

Treatment:

Drug: Indacaterol

Drug: Placebo

Procedure: photoplethysmography

Drug: Tiotropium

Drug: Glycopyrronium

Arm 2

Experimental group

Description:

The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol

Treatment:

Drug: Indacaterol

Drug: Placebo

Procedure: photoplethysmography

Drug: Tiotropium

Drug: Glycopyrronium

Arm 3

Experimental group

Description:

The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,

Treatment:

Drug: Indacaterol

Drug: Placebo

Procedure: photoplethysmography

Drug: Tiotropium

Drug: Glycopyrronium

Arm 4

Experimental group

Description:

The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium

Treatment:

Drug: Indacaterol

Drug: Placebo

Procedure: photoplethysmography

Drug: Tiotropium

Drug: Glycopyrronium