Phase 3b Study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fuumarate and Glycopyrronium/Formoterol Fumarate on Specific Image based Airway Volumes and Resistance in Subjects with Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-001704-10-NL
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
-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
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of BGF and GFF on specific image-based airway volumes and<br>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<br><br>To assess the effects of BGF and GFF on lung function parameters<br><br>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 Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in: <br><br>-Airway Volume and Airway Resistance <br><br>-Forced expiratory volume in one second<br><br>-Functional Residual Capacity;Timepoint(s) of evaluation of this end point: Day 29