Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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Keep this study
Lead
AstraZeneca
With
Parexel International Ltd
Cognizant Technology Solution
CISCRP
eResearchTechnology
QuintilesIMS Limited
Corporate Translations Inc
Age
40–95
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 40-95 years at screening
Current or former smoker with a history of at least 10 pack-years of cigarette smoking
Current clinical diagnosis of COPD, with COPD symptoms \> 1 year prior to screening, as defined by GOLD criteria or other current guidelines
COPD Severity defined by FEV1/FVC ratio \<0.70 and FEV1 \<80% of predicted normal value at screening and at randomisation
COPD treatment with rescue medication only, or stable dose of maintenance monotherapy (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or ICS/LABA), for one month prior to screening
COPD Assessment Test (CAT) score ≥10 at randomisation
Documentation of a chest x-ray (as per local practice) or computed tomography (CT) within 6 months prior to screening, with no clinically significant pulmonary abnormalities other than related to COPD
You may not be if
Respiratory disease other than COPD, including:
Current diagnosis of asthma
Alpha-1 Antitrypsin Deficiency as the cause of COPD
Other respiratory disorders and conditions as listed in the protocol
Severe COPD exacerbation (resulting in hospitalisation) not resolved within 8 weeks prior to screening, or moderate exacerbation not resolved within 4 weeks, or during screening
Pneumonia or lower respiratory tract infection that required antibiotics within 8 weeks prior to screening, or during screening.
Significant diseases or conditions other than COPD which may put the patient at risk, or influence the results of the study or the patient's ability to participate, including cardiac disease, advanced renal disease, and cancer that has not been in complete remission for at least 5 years.
Patients who have needed additions or alterations to their usual maintenance therapy for COPD due to worsening symptoms within 1 month prior to and during screening
Treatment with depot corticosteroids within 6 weeks, or other systemic corticosteroids within 4 weeks, prior to screening. (Patients maintained on an equivalent of 5 mg prednisone per day for at least 3 months prior to screening are allowed.)
Clareo Health | Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
