Clinical trial NCT04087590: Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Official title: Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Copd
Keywords: long acting bronchodilator
tidal breathing
variability
impulse oscillometry spirometry
plethysmography
dyspnea
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-09-12
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

* 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Analysis of tidal volume (VT) complexity (noise limit as main parameter )
timeFrame: at 1 month
Secondary outcomes:
measure: change of frequency-tidal volume pattern
timeFrame: Baseline, at 1 month
measure: Tidal volume Largest Lyapunov component (an indicator of the sensitivity of the system to initial conditions)
timeFrame: Baseline, at 1 month
measure: change of resistance at 5Hz , at 20 Hz
timeFrame: Baseline, at 1 month
measure: Change of reactance
timeFrame: Baseline, at 1 month
measure: Change of AX and resonant frequency
timeFrame: Baseline, at 1 month
measure: change of spirometry parameters
timeFrame: at 1 month
measure: change in lung function as assessed through body plethysmography
timeFrame: Baseline, at 1 month
measure: change of airway resistance (RAW) and specific airway conductance (sGAW).
timeFrame: Baseline, at 1 month
measure: Visual Analogic Scale
timeFrame: Baseline, at 1 month
measure: Likert scales
timeFrame: Baseline, at 1 month
measure: BDI/TDI
timeFrame: Baseline, at 1 month
measure: mMRC dyspnea scale
timeFrame: Baseline, at 1 month
measure: Modified Dyspnea Profile (MDP)
timeFrame: Baseline, at 1 month
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Calmette Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Thierry PEREZ, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: