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

NCT04087590 | Terminated Phase 2 DMC

• 2 other identifiers: 2018_242018-003061-33
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd

Keywords

long acting bronchodilator; tidal breathing; variability; impulse oscillometry spirometry; plethysmography; dyspnea

Outcome Measures

Primary Outcomes (1)

• 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

  at 1 month

Secondary Outcomes (13)

• change of frequency-tidal volume pattern

  Baseline, at 1 month

• Tidal volume Largest Lyapunov component (an indicator of the sensitivity of the system to initial conditions)

  Baseline, at 1 month

• change of resistance at 5Hz , at 20 Hz

  Baseline, at 1 month

• Change of reactance

  Baseline, at 1 month

• Change of AX and resonant frequency

  Baseline, at 1 month

Study Arms (1)

PT003 treatment

EXPERIMENTAL

Drug: Formoterol-glycopyrronium co suspension (PT003)

Interventions

Formoterol-glycopyrronium co suspension (PT003) DRUG

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

PT003 treatment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• AstraZeneca: collaborator

Study Sites (1)

Hop Calmette Chu Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Thierry PEREZ, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: September 12, 2019
• Study Start: January 14, 2020
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: February 20, 2026

Record last verified: 2022-08

Locations

FR (1)