A Randomized, Double-blind, Two Treatment, Two Period, Chronic dosing (4 weeks), Crossover, Multi-center Pilot study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image based Airway Volumes and Resistance in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease

Phase 3

Completed

Conditions: COPD
lung disease
10038716

Registration Number: NL-OMON48928

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Subject must be 40 years to *80 years of age inclusive, at the time of
signing the informed consent form at Visit 1., - COPD Diagnosis: Subjects with
an established clinical history of COPD , - Screening clinical laboratory tests
must be acceptable to the Investigator., - Screening ECG must be acceptable to
the Investigator, - Individual Compliance: Subjects must be willing to remain
at the study center as required per protocol to complete all visit assessments,
- Patients should be on scheduled maintenance treatment with one or more
inhaled bronchodilator therapies.

Exclusion Criteria

- As judged by the investigator, any evidence of significant diseases other
than COPD, i.e., disease or condition which, in the investigator*s opinion
makes it undesirable for the subject to participate in the trial., - Spirometry
Performance:
1) Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS
acceptability criteria., 2) Repeatability: Subjects who cannot perform
technically acceptable spirometry in accordance with ATS repeatability criteria
, - Cancer: Subjects who have cancer that has not been in complete remission
for at least five years., - Substance Abuse: Subjects, who in the opinion of
the Investigator, significantly abuse alcohol or drugs, - Subjects who in the
opinion of the investigator are unable to abstain from prohibited medications
including LABA/LAMAs/ICS

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effects of BGF and GFF on specific image-based airway volumes and<br /><br>resistance in subjects with moderate to severe COPD following chronic<br /><br>twice-daily (BID) dosing after approximately four weeks of treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effects of BGF and GFF on various Functional Respiratory Imaging<br /><br>(FRI) parameters<br /><br><br /><br>To assess the effects of BGF and GFF on lung function parameters<br /><br><br /><br>To assess the effects of BGF and GFF on body plethysmography parameters<br /><br><br /><br>To assess the safety of BGF and GFF through incidence of Adverse events (AEs),<br /><br>serious adverse events (SAEs), adverse events leading to treatment<br /><br>discontinuation (DAEs)</p><br>