Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Product Name: 7.2 mcg glycopyrronium/4.8 mcg formoterol fumarate per actuation
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Glycopyrronium Bromide
CAS Number: 596-51-0
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female or male patients aged 40-95 years inclusive at the time of enrolment at screening 3. Tobacco Use: Current or former smoker with a history of at least 10 pack-years of cigarette smoking (1 pack year = 20 cigarettes smoked per day for 1 year) 4. A current clinical diagnosis of COPD, with COPD symptoms for more than 1 year prior to screening, as defined by GOLD criteria or other current guidelines 5. COPD Severity defined as: - At screening visits, post-bronchodilator FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: 1. Respiratory disease: - Current diagnosis of asthma - Alpha-1 Antitrypsin Deficiency as the cause of COPD - Other respiratory disorders: active tuberculosis, lung cancer, clinically significant bronchiectasis disease, sarcoidosis, IPF, primary pulmonary hypertension, or uncontrolled sleep apnea - Patients who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction in 1yr of screening - Severe COPD exacerbation (resulting in hospitalisation) not resolved in 8wk prior to screening, or moderate not resolved in 4wk, or moderate or severe during screening - Pneumonia or lower respiratory tract infection that required antibiotics in 8wk prior to or during screening - Risk factors for pneumonia: immune suppression (HIV), severe neurological disorders affecting control of the upper airway or other risk factors that would put patients at substantial risk of pneumonia - Patients receiving long-term-oxygen therapy or nocturnal oxygen therapy required>12h/day - Patient use of any non-invasive positive pressure ventilation device. Note: Patients using continuous positive airway pressure or bi-level positive airway pressure for sleep apnea syndrome are allowed if not used for ventilatory support - Patients who have participated in the acute phase of a pulmonary rehabilitation in 4wk prior to screening or who will enter the acute phase of a pulmonary rehabilitation during screening. Allowed in the maintenance phase 2. Cardiac disease: - Unstable angina/acute coronary syndrome, or CABG, PCI or myocardial infarction within the past 6 months. - CHF NYHA class III/IV - Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease) - Paroxysmal (in past 6mths) or symptomatic chronic cardiac tachyarrhythmia - LBB or high-degree AV block (2 and 3 degree) unless using pacemaker - Sinus node dysfunction with pauses - Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome - QTcF interval >470 msec (corrected using Fridericia's formula) - Any other ECG abnormality deemed clinically significant - Bradycardia with ventricular rate 165/95mmHg 3. Patients with a calculated eGFR <30mL/min using CKD-EPI formula 4. Patients who have cancer that has not been in complete remission for at least 5yrs 5. Patients with a diagnosis of narrow-angle glaucoma that hasn't been adequately treated. All medications approved for control of intraocular pressures are allowed 6. Patients with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant 7. Significant diseases or conditions other than COPD which may put the patient at risk, influence the results of the study or the patient's ability to participate 8. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalyses, vital signs or ECG which may put the patient at risk 9. Pregnant or lactating women, or if planning to become pregnant during the study, or women of childbearing potential who are not using an acceptable method of contraception 10. Patients who have a history of hypersensitivity to ß2 agonists, GP or other muscarinic anticholinergics, or any component of the MDI or DPI 11. Patients who abuse alcohol or drugs 12. Patients who are medically unable to withhold their short-acting bronchodilators for 6h prior to spirometry at study visits 13. Patients who would be unable to abstai
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of GFF relative to UV on lung function as measured by trough FEV1 in patients with moderate to very severe COPD;Secondary Objective: 1. To further assess the effects of GFF relative to UV on lung function. 2. To assess the effects of GFF relative to UV on dyspnea 3. To assess the effects of GFF relative to UV on symptoms of COPD 4. To assess the effects of GFF relative to UV on health-related quality of life;Primary end point(s): Change from baseline in morning pre-dose trough FEV1 (Forced Expiratory Volume in 1 second);Timepoint(s) of evaluation of this end point: 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Onset of action on day 1; proportion of patients with increase of FEV1 of =100 ml from baseline at 5 minutes Change from baseline in Peak FEV1 within 2 hours post-dosing Change from baseline in Peak Inspiratory Capacity (IC) within 2 hours post-dosing Transition Dyspnea Index (TDI) focal score Change from baseline in Early Morning Symptoms COPD Instrument (EMSCI);Timepoint(s) of evaluation of this end point: 5 minutes on Day 1 for early onset, 24 weeks for all other endpoints | — |
Countries
Bulgaria, Canada, France, Hungary, Russian Federation, Ukraine, United States
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed