Informations générales (source: ClinicalTrials.gov)
Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Interventional
Phase 2
University Hospital, Lille (Voir sur ClinicalTrials)
janvier 2020
mars 2023
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Philippe DEVILLIER | 11/05/2026 07:25:46 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hop Calmette Chu Lille - 59000 - Lille 2998324 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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