CopdPhase 2OSCIVARINCT04087590
Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
A Phase 2 study testing Formoterol-glycopyrronium co suspension (PT003) in people with Copd, run by University Hospital, Lille at 1 site in France.
Trial summary
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe COPD patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Copd
- What is being tested?
- Formoterol-glycopyrronium co suspension (PT003)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2020to 23 Mar 2023
- Phase
- Phase 2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subjects aged 40-75 years Documented COPD in stable condition FEV1 between 30 % and 70 % predicted (post bronchodilator) Significant dyspnea with a mMRC dyspnea scale
Who cannot join
- History or current diagnosis of asthma or ACO (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
- Severe renal impairment eGFR < 30
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe COPD patients.
- Variability and complexity of resting tidal breathing
- Oscillatory resistance and reactance of airways Tidal volume variability and complexity is decreased in airway obstruction and is expected to improve with a bronchodilator treatment, together with lung mechanics.
Read more
The relationship with changes in dyspnea and conventional pulmonary function tests is the second aim of study.
After baseline assessment of these parameters, clinical and lung function evaluation will be performed 2 hours post-drug (peak drug effects). Patients will continue treatment with PT003 for 4 weeks. On Day 30, the same clinical and lung function assessments will be performed pre (trough) and 2h-post dose in order to obtain after-treatment measurements.
- Conditions
- Copd
- Being tested
- Formoterol-glycopyrronium co suspension (PT003)
- Keywords
- long acting bronchodilator, tidal breathing, variability, impulse oscillometry 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.
Formoterol-glycopyrronium co suspension (PT003)Drug
Formoterol-glycopyrronium co suspension (PT003) in a Metered Dose Inhaler, 2 puffs twice daily
| Study group | Role | What they receive |
|---|---|---|
| PT003 treatment | Experimental | Not described Receives: Drug: Formoterol-glycopyrronium co suspension (PT003) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of tidal volume (VT) complexity (noise limit as main parameter )
Comparison of the noise limit between V2 baseline (pre-treatment) and V3 peak (2 hours +/- 30 min post dose).
Noise limit is a mathematical treatment of tidal breathing signal evaluating its complexity and no other description can be provided
Measured: at 1 month
Secondary outcomes (13)
change of frequency-tidal volume pattern
the inspiratory time (Ti, measured in second) , the expiratory time (Te,measured in second) and the respiratory frequency
Measured: Baseline, at 1 month
Tidal volume Largest Lyapunov component (an indicator of the sensitivity of the system to initial conditions)
Measured: Baseline, at 1 month
change of resistance at 5Hz , at 20 Hz
The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Resistance is complex measure that incorporates the lack of changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency.
All these measurements are expressed in the same unit (for resistance and reactance) and refer to oscillatory mechanics obtained by the same device. AX and resonant frequency are correlated to reactance.
Measured: Baseline, at 1 month
Change of reactance
the fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency at 5Hz was used. Reactance is thought to reflect the elastic properties of the lung.
All these measurements are expressed in the same unit (for resistance and reactance) and refer to oscillatory mechanics obtained by the same device.
Measured: Baseline, at 1 month
Change of AX and resonant frequency
Area under reactance curve (AX) and resonant frequency are correlated to reactance.
Measured: Baseline, at 1 month
change of spirometry parameters
Spirometry : FEV1, FVC, FEV1/FVC
Measured: at 1 month
change in lung function as assessed through body plethysmography
Change from baseline to end of treatment in the following measures Total lung capacity (TLC) Residual volume (RV) Inspiratory capacity (IC) Functional residual capacity (FRC) All plethysmographic parameters shown here are lung volumes, expressed in liters, and are somewhat interrelated. For instance IC is TLC- FRC.There is no reason to separate these outcome measures
Measured: Baseline, at 1 month
change of airway resistance (RAW) and specific airway conductance (sGAW).
sGaw is specific conductance, ie 1/resistance divided by the volume at which resistance was measured. These two parameters are always measured and used together.
All plethysmographic parameters shown here are lung volumes, expressed in liters, and are somewhat interrelated.
Measured: Baseline, at 1 month
Visual Analogic Scale
Two VAS (± 100 mm ) will be used to evaluate changes (much worse-unchanged-much better) in dyspnea and chest tightness 2 hours after PT003 administration and at 4 weeks in through and post dose conditions
Measured: Baseline, at 1 month
Likert scales
Likert scales (7 points) will assess changes in dyspnea and global health at visit 3 in comparison with pre treatment condition (V2).
Measured: Baseline, at 1 month
BDI/TDI
The BDI/TDI is an instrument developed to provide a multidimensional measure of dyspnea in relation to activities of daily living. The Baseline Dyspnea Index (BDI) provides a measure of dyspnea at a single state, the baseline, and the Transitional Dyspnea Index (TDI) evaluates changes in dyspnea from the baseline state. The instrument consists of three components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these three components are rated in five grades from 0 (severe) to 4 (unimpaired), and are summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea are rated for each component by seven grades from -3 (major deterioration) to +3 (major improvement), and are added to form a total TDI score from -9 to +9. Positive scores indicate an improvement, and a change from the BDI or a difference between treatments of 1 point has been estimated to constitute the minimum clinically important difference (MC
Measured: Baseline, at 1 month
mMRC dyspnea scale
The Modified Medical Research Council (mMRC) dyspnea scale uses a simple grading system to assess a subject's level of dyspnea that consists of five statements about perceived breathlessness. It is an interviewer-administered ordinal scale on which subjects provide their dyspnea according to five grades of increasing severity (scores ranges from 0 (none) to 4 (very severe).
Measured: Baseline, at 1 month
Modified Dyspnea Profile (MDP)
The MDP consists of 11 items evaluating both the sensory and affective dimensions of dyspnoea. One item (A1) assesses the unpleasantness of dyspnoea on a 0-10 visual numerical scale anchored by "neutral" (0) and "unbearable" (10). Five items assess the sensory dimension of dyspnoea, both in terms of quality and intensity (on a scale of 0-10). Five items assess the affective dimension of dyspnoea, also in terms of quality and intensity (on a scale of 0-10).
Measured: Baseline, at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start14 Jan 2020
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Why it stopped: Following Brexit and the unavailability of the experimental drug (PT003) in France, the study was terminated prematurely.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Thierry PEREZ, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087590
- Sponsor's protocol ID
- 2018_24
- Other IDs
- 2018-003061-33, 2018
- Acronym
- OSCIVARI
- Status last verified
- Aug 2022
- First submitted
- 10 Jul 2019
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
- ClinicalTrials.gov ID
- NCT04087590
- Acronym / sponsor ID
- OSCIVARI / 2018_24
- Conditions
- Copd
- Keywords
- long acting bronchodilator, tidal breathing, variability, impulse oscillometry spirometry, plethysmography, dyspnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following Brexit and the unavailability of the experimental drug (PT003) in France, the study was terminated prematurely.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 12 Sep 2019 (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.
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe COPD patients.
- Variability and complexity of resting tidal breathing
- Oscillatory resistance and reactance of airways Tidal volume variability and complexity is decreased in airway obstruction and is expected to improve with a bronchodilator treatment, together with lung mechanics.
The relationship with changes in dyspnea and conventional pulmonary function tests is the second aim of study.
After baseline assessment of these parameters, clinical and lung function evaluation will be performed 2 hours post-drug (peak drug effects). Patients will continue treatment with PT003 for 4 weeks. On Day 30, the same clinical and lung function assessments will be performed pre (trough) and 2h-post dose in order to obtain after-treatment measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PT003 treatment | Experimental | Drug: Formoterol-glycopyrronium co suspension (PT003) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female or male subjects aged 40-75 years Documented COPD in stable condition FEV1 between 30 % and 70 % predicted (post bronchodilator) Significant dyspnea with a mMRC dyspnea scale
Key exclusion criteria (6 listed)
- History or current diagnosis of asthma or ACO (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
- Severe renal impairment eGFR < 30
- Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
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 |
|---|---|---|
| Formoterol-glycopyrronium co suspension (PT003)Formoterol-glycopyrronium co suspension (PT003) in a Metered Dose Inhaler, 2 puffs twice daily | Drug | PT003 treatment |
Primary outcome
Analysis of tidal volume (VT) complexity (noise limit as main parameter )
Time frame: at 1 month
Comparison of the noise limit between V2 baseline (pre-treatment) and V3 peak (2 hours +/- 30 min post dose). Noise limit is a mathematical treatment of tidal breathing signal evaluating its complexity and no other description can be provided
13 secondary outcomes
change of frequency-tidal volume pattern
Time frame: Baseline, at 1 month
Tidal volume Largest Lyapunov component (an indicator of the sensitivity of the system to initial conditions)
Time frame: Baseline, at 1 month
change of resistance at 5Hz , at 20 Hz
Time frame: Baseline, at 1 month
Change of reactance
Time frame: Baseline, at 1 month
Change of AX and resonant frequency
Time frame: Baseline, at 1 month
change of spirometry parameters
Time frame: at 1 month
change in lung function as assessed through body plethysmography
Time frame: Baseline, at 1 month
change of airway resistance (RAW) and specific airway conductance (sGAW).
Time frame: Baseline, at 1 month
Visual Analogic Scale
Time frame: Baseline, at 1 month
Likert scales
Time frame: Baseline, at 1 month
BDI/TDI
Time frame: Baseline, at 1 month
mMRC dyspnea scale
Time frame: Baseline, at 1 month
Modified Dyspnea Profile (MDP)
Time frame: Baseline, at 1 month
Results and safety
The study was stopped early (reason given: Following Brexit and the unavailability of the experimental drug (PT003) in France, the study was terminated prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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. This study is not recruiting at the moment.
Thierry PEREZ, MD,PhD 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 2 study testing Formoterol-glycopyrronium co suspension (PT003) 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Feb 2026. 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 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?
The study was stopped early (reason given: Following Brexit and the unavailability of the experimental drug (PT003) in France, the study was terminated prematurely.). Results are not available in the source record.
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?
Analysis of tidal volume (VT) complexity (noise limit as main parameter ) (time frame: at 1 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 20 Feb 2026.