COPD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Outpatient or inpatient 2. Subjects must give their signed and dated written informed consent to participate. 3. Male or female subjects: A female is eligible to enter and participate in the study if she is of Non-child bearing potential. 4. Aged 40 to 70 years; 5. Patients diagnosed with chronic obstructive pulmonary disease for more than 12 months, or patients with chronic obstructive pulmonary disease complicated with anxiety / depression. COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society (ATS) /European Respiratory Society(ERS).
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. Women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD); 3. The subjects were diagnosed as anxiety disorder and / or depression or comorbidity before the history of chronic obstructive pulmonary disease; 4. Other respiratory disorders: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases; 5. Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, 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; 6. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the site investigator, contraindicates the subjects participation will also be excluded; 7. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lung function;clinlcal symptom;Drug compliance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton anxiety / Depression Scale score;CAT score;mMRC score;routine blood test; | — |
Countries
China
Contacts
Xinqiao Hospital