Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Budesonide Glycopyrronium Formoterol Fumarate
Product Code: PT010
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Other des
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of BGF and GFF on specific image-based airway volumes and resistance in subjects with moderate to severe COPD;Secondary Objective: To assess the effects of BGF and GFF on various Functional Respiratory Imaging (FRI) parameters To assess the effects of BGF and GFF on lung function parameters To assess the effects of BGF and GFF on body plethysmography parameters;Primary end point(s): Change from baseline to the specific airway volume and Specific airway resistance in each treatment.;Timepoint(s) of evaluation of this end point: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in: -Airway Volume and Airway Resistance -Forced expiratory volume in one second -Functional Residual Capacity;Timepoint(s) of evaluation of this end point: Day 29 | — |
Countries
Belgium, Netherlands
Contacts
Public ContactInformation Centter
AstraZeneca AB
Outcome results
None listed