Overview

Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient

Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Lille
Collaborator:
AstraZeneca
Treatments:
Formoterol Fumarate
Glycopyrrolate
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