Chronic Obstructive Pulmonary DiseasePhase 4LAB-CardNCT02872090
Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Indacaterol, Glycopyrronium and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol, Glycopyrronium and Tiotropium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with FEV1 / FVC <70%
Who cannot join
- beta blocker
- supraventricular rhythm disorder
- previous history of respiratory disease other than COPD
- diabetes
- autonomic dysfunction
- dysautonomia
Show all 9Show fewer
- renal failure
- long-term oxygen therapy
- history of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD
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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol, Glycopyrronium, Tiotropium, Placebo, photoplethysmography
- Keywords
- COPD, bronchodilatators, autonomic nervous system, cardiovascular system
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndacaterolDrug
inhalation
GlycopyrroniumDrug
inhalation
TiotropiumDrug
inhalation
PlaceboDrug
photoplethysmographyProcedure or surgery
inhalation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo Receives: Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography |
| Arm 2 | Experimental | The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol Receives: Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography |
| Arm 3 | Experimental | The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium, Receives: Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography |
| Arm 4 | Experimental | The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium Receives: Drug: Indacaterol; Drug: Glycopyrronium; Drug: Tiotropium; Drug: Placebo; Procedure: photoplethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (6)
Slope of baroreflex in supine position
Drugs vs placebo
Measured: 10 minutes
LF / HF ratio derived from the spectral analysis of R-R intervals measured after verticalisation during a tilt table test
Drugs vs placebo
Measured: 10 minutes
Total spectral power during a tilt table tes
Drugs vs placebo
Measured: 20 minutes
Value of HF (gross value then normalized according to the average R-R interval) during a tilt table tes
Drugs vs placebo
Measured: 20 minutes
RMSSD (Root Mean Square of the Successive Differences) index during a tilt table test
Drugs vs placebo
Measured: 20 minutes
Variability in blood pressure during a tilt table test
Drugs vs placebo
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startMar 2016
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu VEIL-PICARD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872090
- Sponsor's protocol ID
- P/2015/255
- Acronym
- LAB-Card
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2016
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD
- ClinicalTrials.gov ID
- NCT02872090
- Acronym / sponsor ID
- LAB-Card / P/2015/255
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, bronchodilatators, autonomic nervous system, cardiovascular system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Indacaterol, Drug: Glycopyrronium, Drug: Tiotropium, Drug: Placebo, Procedure: photoplethysmographyThe 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: photoplethysmographyThe 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: photoplethysmographyThe 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: photoplethysmographyThe patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with FEV1 / FVC <70%
Key exclusion criteria (9 listed)
- beta blocker
- supraventricular rhythm disorder
- previous history of respiratory disease other than COPD
- diabetes
- autonomic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indacaterolinhalation | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| Glycopyrroniuminhalation | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| Tiotropiuminhalation | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| Placebo | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| photoplethysmographyinhalation | Procedure or surgery | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
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.
6 secondary outcomes
Slope of baroreflex in supine position
Time frame: 10 minutes
LF / HF ratio derived from the spectral analysis of R-R intervals measured after verticalisation during a tilt table test
Time frame: 10 minutes
Total spectral power during a tilt table tes
Time frame: 20 minutes
Value of HF (gross value then normalized according to the average R-R interval) during a tilt table tes
Time frame: 20 minutes
RMSSD (Root Mean Square of the Successive Differences) index during a tilt table test
Time frame: 20 minutes
Variability in blood pressure during a tilt table test
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu VEIL-PICARD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indacaterol, Glycopyrronium and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-frequency (LF)/High-frequency (HF) ratio in supine position during a tilt table test after bronchodilators inhalation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.