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

NCT04087590 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Formoterol-glycopyrronium co suspension (PT003)

Formoterol-glycopyrronium co suspension (PT003) in a Metered Dose Inhaler, 2 puffs twice daily

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Thierry PEREZ, MD,PhD · University Hospital, Lille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2023-03-23
Completion
2023-03-23

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087590 on ClinicalTrials.gov