Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD
| Registry | NCT02872090, acronym LAB-Card |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, crossover, masking: quadruple, treatment |
| Enrollment | 42 (Actual) |
| Sponsor | Centre Hospitalier Universitaire de Besancon (Other) |
| Conditions | Chronic Obstructive Pulmonary Disease |
| Interventions | Indacaterol, Glycopyrronium, Tiotropium, Placebo, photoplethysmography (Drug, procedure) |
| Dates | start 2016-03-01, primary completion 2021-06-01, completion 2021-06-01, first posted 2016-08-18, last updated 2021-08-03 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Obstructive Pulmonary Disease All trials of Indacaterol All trials of Glycopyrronium
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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1 | Experimental | Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography | The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo |
| Arm 2 | Experimental | Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography | The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol |
| Arm 3 | Experimental | Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography | The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium, |
| Arm 4 | Experimental | Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography | The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium |
Sex: All, ages: 50 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Hospitalier Régional Universitaire | Besançon | France |