Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02872090
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Indacaterol Drug: Glycopyrronium Drug: Tiotropium Drug: Placebo Procedure: photoplethysmography Phase 4

Detailed 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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
Drug: Indacaterol
inhalation

Drug: Glycopyrronium
inhalation

Drug: Tiotropium
inhalation

Drug: Placebo
Procedure: photoplethysmography
inhalation

Experimental: Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
Drug: Indacaterol
inhalation

Drug: Glycopyrronium
inhalation

Drug: Tiotropium
inhalation

Drug: Placebo
Procedure: photoplethysmography
inhalation

Experimental: Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
Drug: Indacaterol
inhalation

Drug: Glycopyrronium
inhalation

Drug: Tiotropium
inhalation

Drug: Placebo
Procedure: photoplethysmography
inhalation

Experimental: Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
Drug: Indacaterol
inhalation

Drug: Glycopyrronium
inhalation

Drug: Tiotropium
inhalation

Drug: Placebo
Procedure: photoplethysmography
inhalation




Primary Outcome Measures :
  1. Low-frequency (LF)/High-frequency (HF) ratio in supine position during a tilt table test after bronchodilators inhalation [ Time Frame: 10 minutes ]
    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.


Secondary Outcome Measures :
  1. Slope of baroreflex in supine position [ Time Frame: 10 minutes ]
    Drugs vs placebo

  2. LF / HF ratio derived from the spectral analysis of R-R intervals measured after verticalisation during a tilt table test [ Time Frame: 10 minutes ]
    Drugs vs placebo

  3. Total spectral power during a tilt table tes [ Time Frame: 20 minutes ]
    Drugs vs placebo

  4. Value of HF (gross value then normalized according to the average R-R interval) during a tilt table tes [ Time Frame: 20 minutes ]
    Drugs vs placebo

  5. RMSSD (Root Mean Square of the Successive Differences) index during a tilt table test [ Time Frame: 20 minutes ]
    Drugs vs placebo

  6. Variability in blood pressure during a tilt table test [ Time Frame: 20 minutes ]
    Drugs vs placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872090


Contacts
Layout table for location contacts
Contact: Matthieu VEIL-PICARD matthieuveil@gmail.com

Locations
Layout table for location information
France
Centre Hospitalier Régional Universitaire Recruiting
Besançon, France
Contact: Elise ROBERT       e1robert@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Layout table for investigator information
Principal Investigator: Matthieu VEIL-PICARD CHU Besançon

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02872090     History of Changes
Other Study ID Numbers: P/2015/255
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
COPD
bronchodilatators
autonomic nervous system
cardiovascular system

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action