A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort Turbuhaler as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PT010006)

The requested reference [15f2a2ca40d6f2fd3b484ab7ee1e4d28b316d162] no longer exists in our database. It has been replaced by the current reference: [f2629013bfbec5104b02f52a4ed7b3b42fbca2ab]

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2018
INTERVENTION: Intervention name : BGF MDI (PT010) 320/14.4/9.6 micrograms Dosage And administration of the intervention : BGF MDI (PT010) 320/14.4/9.6 micrograms ex‐actuator : BGF MDI 320/14.4/9.6 micrograms, Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol Intervention name : GFF MDI (PT003) 14.4/9.6 micrograms Dosage And administration of the intervention : GFF MDI (PT003) 14.4/9.6 micrograms ex‐actuator : GFF MDI 14.4/9.6 micrograms ex‐actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol Intervention name : BFF MDI (PT009) 320/9.6 micrograms Dosage And administration of the intervention : BFF MDI (PT009) 320/9.6 micrograms ex‐actuator : BFF MDI 320/9.6 micrograms, Budesonide, Formoterol Fumarate Inhalation Aerosol Control intervention name : Symbicort Turbuhaler (TBH) Inhalation Powder Dosage And administration of the control intervention : Symbicort Turbuhaler (TBH) Inhalation Powder 200/6 micrograms CONDITION: COPD INCLUSION CRITERIA: ‐Given their signed written informed consent to participate. ‐Non‐child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post‐menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study. ‐Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines. ‐Current or former smokers with a history of at least 10 pack‐years of cigarette smoking. ‐Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions). ‐Required COPD maintenance therapy: ‐All Subjects
Epistemonikos ID: e13501e75f4637c06798dd5ec579161eafc8a412
First added on: Aug 24, 2024