Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Test group:GFF MDI two inhalations twice daily
Control Group:placebo MDI two inhalations twice daily
Sponsors
The First Affilated Hospital of Guangzhou Medical Universtiy
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: Participants must be 40 to 80 years of age inclusive, at Visit 1. 2. Sex: Male or female A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). OR Child bearing potential, has a negative pregnancy test at screening, and agree to take effective contraceptive measures consistently and correctly, (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to safety follow-up contact) 3. Informed Consent A signed and dated written informed consent (Appendix A) prior to study participation. 4. COPD Diagnosis An established clinical history of COPD in accordance with the definition by the American Thoracic Society OR a post-bronchodilator FEV1/FVC ratio of = 50% and = 10 pack-years at screening (visit 1) . 7. Capability of proper use of pMDI. 8. Compliance Subjects must be willing to complete all visit assessments per protocol.
Exclusion criteria
Exclusion criteria: Medical Conditions 1. As judged by the investigator, any evidence of significant diseases or conditions other than COPD which in the investigator's opinion, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 2. History of respiratory disease: a. Subjects with prior history of asthma (including cough variant asthma) or in the opinion of the investigator, have a current diagnosis of asthma. b. Alpha-1 Antitrypsin Deficiency: Subjects who have alpha-1 antitrypsin deficiency as the cause of COPD. c. Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. d. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening Visit. e. COPD exacerbation (defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics) in 8 weeks prior to the Visit 1 or during Visit 1 to Visit 2. f. Lower Respiratory Tract Infection: Subjects who had lower respiratory tract infections that has not been fully resolved 30 days prior to Visit 1. 3. Exacerbation history Subjects with severe exacerbation history within the last 12 months prior to Visit 1. 4. Prohibited Medications Prior to Screening or During the Study. 5. Allergy or intolerance to the study drug. Participants with a known hypersensitivity to formoterol or any other ß2-agonists, glycopyrrolate, or other muscarinic anticholinergics, or any component of the MDI device, or any of the excipients of the product. Other Exclusions 1. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 2. For women only - preparing for pregnancy or currently pregnant (confirmed with positive pregnancy test) or breast-feeding. 3. History of chronic alcohol, beta-adrenergic blockers (including eye drops) or drug abuse that may impact compliance. 4. Hand-to-Breath Coordination: Subjects who requires the use of a spacer device to compensate for poor hand-to-breath coordination with a MDI. 5. Subjects who cannot complete patient diary during screening/run-in period. 6. Subjects who are currently involved in any other interventional studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spirometry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bronchodilator response;Chest CT;COPD clinical questionaire (CCQ);COPD assessment test (CAT);Impulse oscillometry;Visual analogue scale;COPD exacerbations;Airflow limitation in small airway; | — |
Countries
Cina
Contacts
Public ContactZheng Jinping
The First Affilated Hospital of Guangzhou Medical Universtiy
Outcome results
None listed