Status:
COMPLETED
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fuma...
Detailed Description
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fum...
Eligibility Criteria
Inclusion
- 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
- 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:
- Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS acceptability criteria.
- 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
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03836677
Start Date
February 26 2019
End Date
November 11 2019
Last Update
February 11 2021
Active Locations (4)
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1
Research Site
Erpent, Belgium, 5101
2
Research Site
Eindhoven, Netherlands, 5623 EJ
3
Research Site
Groningen, Netherlands, 9713 GZ
4
Research Site
Zutphen, Netherlands, 7207 AE