CopdPhase 1/2VARI-OSCILNCT06110403
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
A Phase 1/2 study testing TRIXEO AEROSPHERE in people with Copd, run by University Hospital, Lille at 1 site in France.
Trial summary
Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Copd
- What is being tested?
- TRIXEO AEROSPHERE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2023to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed informed consent prior to any study specific procedure
- Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)
- Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator 30 % < FEV1 <70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening
- Smoking history > 10 pack-years
- Baseline significant dyspnea with a mMRC ≥ 2
Who cannot join
- History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)
- Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
- Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters:
- Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months.
- Congestive heart failure New York Heart Association (NYHA) class III/IV.
- Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease).
Show all 27Show fewer
- Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia.
- Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker.
- Sinus node dysfunction with pauses.
- Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome.
- QTcF interval >470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/[RR1/3]).
- Any other ECG abnormality deemed clinically significant by the Investigator.
- Bradycardia with ventricular rate < 45 bpm.
- Uncontrolled hypertension (> 165/95 mmHg).
- Clinically relevant respiratory conditions (other than COPD)
- Severe renal impairment eGFR < 30
- Hepatic impairment
- Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
- Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
- Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min)
- Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids
- Pregnancy or breastfeeding
- Woman of childbearing age without effective contraception
- Any type of cancer within 5 years
- Patients under guardianship
- Refuse or incapacity to give an informed consent
- Absence of social insurance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille
Thierry PEREZ, md
Thierry PEREZ, md
About this study
Official title: Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability
- Conditions
- Copd
- Being tested
- TRIXEO AEROSPHERE
- Keywords
- COPD, bronchodilator, ventilatory mode, variability, forced oscillations, spirometry, plethysmography, dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIXEO AEROSPHEREDrug
BGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) as an inhalation aerosol. Oral inhalation: 2 inhalations of BGF 160 twice daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Symptomatic COPD patients in stable condition treated with BGF 160 (Trixéo Aerosphere®), a combination of budesonide, formoterol and glycopyrronium in a metered dose inhaler, taken twice a day Receives: Drug: TRIXEO AEROSPHERE |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ventilation pattern complexity and variability
- Noise limit: %
- Lyapounov component: bits/iteration no combination possible
Measured: between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)
Secondary outcomes (9)
Change impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz
resistance and reactance: kPa/L/s
Measured: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Changes in FEV1 (spirometry)
Measured: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Change Plethysmographic Functional residual capacity (FRC)
Measured: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Changes measurement for noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1and FRC versus TDI at V3
TDI at V3 (in term of continuous variable and in term of binary variable "responder/non responder"; a response is defined by a change in TDI ≥ +1 between baseline and V3)
Measured: between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min)
Baseline dyspnea index ( BDI)
Measured: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Transition dyspnea index (TDI)
Measured: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Modified dyspnea profile ( MDP)
Measured: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
CAT score : COPD assessment test,
range 0 to 40, 40 meaning the worst condition
Measured: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes at one month)
Likert scale for dyspnea and general health
Likert scale change in dyspnea : - 3 to + 3, + 3 maximal improvement, -3 maximal deterioration Likert scale change in general health : - 3 to + 3, + 3 maximal improvement, -3 maximal deterioration
Measured: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start29 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Thierry PEREZ, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110403
- Sponsor's protocol ID
- 2022_0422
- Other IDs
- 2022-003784-15
- Acronym
- VARI-OSCIL
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
- ClinicalTrials.gov ID
- NCT06110403
- Acronym / sponsor ID
- VARI-OSCIL / 2022_0422
- Conditions
- Copd
- Keywords
- COPD, bronchodilator, ventilatory mode, variability, forced oscillations, spirometry, plethysmography, dyspnea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- 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.
Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: TRIXEO AEROSPHERESymptomatic COPD patients in stable condition treated with BGF 160 (Trixéo Aerosphere®), a combination of budesonide, formoterol and glycopyrronium in a metered dose inhaler, taken twice a day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed informed consent prior to any study specific procedure
- Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)
- Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator 30 % < FEV1 <70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening
- Smoking history > 10 pack-years
- Baseline significant dyspnea with a mMRC ≥ 2
Key exclusion criteria (27 listed)
- History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)
- Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
- Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters:
- Clinically relevant respiratory conditions (other than COPD)
- Severe renal impairment eGFR < 30
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 |
|---|---|---|
| TRIXEO AEROSPHEREBGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) as an inhalation aerosol. Oral inhalation: 2 inhalations of BGF 160 twice daily for 30 days. | Drug | Experimental group |
Primary outcome
change in ventilation pattern complexity and variability
Time frame: between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)
* Noise limit: % * Lyapounov component: bits/iteration no combination possible
9 secondary outcomes
Change impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz
Time frame: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Changes in FEV1 (spirometry)
Time frame: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Change Plethysmographic Functional residual capacity (FRC)
Time frame: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Changes measurement for noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1and FRC versus TDI at V3
Time frame: between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min)
Baseline dyspnea index ( BDI)
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Transition dyspnea index (TDI)
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Modified dyspnea profile ( MDP)
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
CAT score : COPD assessment test,
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes at one month)
Likert scale for dyspnea and general health
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
Thierry PEREZ, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TRIXEO AEROSPHERE in people with Copd, run by University Hospital, Lille 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 5 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry PEREZ, MD (0320445962 ext. +33, thierry.perez@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in ventilation pattern complexity and variability (time frame: between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)). 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 18 Dec 2025.