NCT02872090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

5.3 years

First QC Date

August 11, 2016

Last Update Submit

August 2, 2021

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDbronchodilatatorsautonomic nervous systemcardiovascular system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Slope of baroreflex in supine position

    10 minutes

  • LF / HF ratio derived from the spectral analysis of R-R intervals measured after verticalisation during a tilt table test

    10 minutes

  • Total spectral power during a tilt table tes

    20 minutes

  • Value of HF (gross value then normalized according to the average R-R interval) during a tilt table tes

    20 minutes

  • RMSSD (Root Mean Square of the Successive Differences) index during a tilt table test

    20 minutes

  • +1 more secondary outcomes

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Drug: IndacaterolDrug: GlycopyrroniumDrug: TiotropiumDrug: PlaceboProcedure: photoplethysmography

Arm 2

EXPERIMENTAL

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

Drug: IndacaterolDrug: GlycopyrroniumDrug: TiotropiumDrug: PlaceboProcedure: photoplethysmography

Arm 3

EXPERIMENTAL

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

Drug: IndacaterolDrug: GlycopyrroniumDrug: TiotropiumDrug: PlaceboProcedure: photoplethysmography

Arm 4

EXPERIMENTAL

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

Drug: IndacaterolDrug: GlycopyrroniumDrug: TiotropiumDrug: PlaceboProcedure: photoplethysmography

Interventions

IndacaterolDRUG

inhalation

Arm 1Arm 2Arm 3Arm 4
GlycopyrroniumDRUG

inhalation

Arm 1Arm 2Arm 3Arm 4
TiotropiumDRUG

inhalation

Arm 1Arm 2Arm 3Arm 4
PlaceboDRUG
Arm 1Arm 2Arm 3Arm 4
photoplethysmographyPROCEDURE

inhalation

Arm 1Arm 2Arm 3Arm 4

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with FEV1 / FVC \<70%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterolGlycopyrrolateTiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Matthieu VEIL-PICARD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 18, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)