Asthma
Conditions
Interventions
Experimental group:beclomethasone dipropionate and formoterol inhalation powder
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Obtain written informed consent before any study related procedure; 2. Healthy Chinese male and female volunteers aged 18 to 45 years; 3. Female subjects of non-childbearing potential (WONCBP): they had to report surgical sterilisation (performed at least 6 months prior to dosing), menopause (had to have no regular menstrual bleeding for at least one year prior to dosing); 4. Female subject with childbearing potential (WOCBP): they had to be using one or more of the following reliable methods of contraception during the study period and at least within 3 months after the last study drug intake: (1) Placement of an intrauterine device (IUD) or intrauterine system (IUS); (2) Hormonal contraception (implantable, patch, oral); (3) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository; (4) Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). 5. Male subjects; they had to be using two effective methods of contraception during the entire study period and not father a child within 3 months after the last study drug intake; 6. Non-smokers or ex-smokers who smoked 1 year prior to screening; 7. Ability to understand study procedure, risks involved and to be trained to correctly use the DPI inhalers (NEXThaler) and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial device; 8. The results of laboratory test had to be within the normal range for the testing laboratory; 9. Body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 inclusive; 10. Good physical and mental health status, determined on the basis of the medical history and a general clinical examination; 11. Blood pressure measured at supine (after 5 min rest at supine) and standing (after 2 min standing) within the following range: systolic blood pressure (SBP): 90-140 mmHg; diastolic blood pressure (DBP): 60 90 mmHg. Blood pressure change between supine and standing had to be: SBP <20 mmHg and DBP <10 mmHg; 12. 12-lead electrocardiogram (ECG) with no clinical significant abnormalities (normal values: QRS <120 ms, PR <210 ms, 45< heart rate (HR) <110 bpm, time interval between the Q and T waves (corrected for the HR) with the Fridericia formula (QTcF) <450 ms, considering the average of triplicate) at screening.
Exclusion criteria
Exclusion criteria: 1. For females only: pregnant or lactating female subject, confirmed by a positive serum pregnancy test at screening and a urine test performed on Day -1 visit; 2. Lung function measurements outside normal limits (i.e., FEV1, forced vital capacity (FVC) or peak expiratory flow (PEF) <80% predicted value, FEV1/FVC ratio <0.70) or other standard value; 3. History or presence of cardiovascular, respiratory, hepatic, endocrinal, renal, gastrointestinal, neurological or any other disorders capable of altering the absorption, metabolism, distribution or elimination of drugs, or constituting a risk factor when taking the study medication; 4. Documented history of drug abuse (within 12 months before screening) and/or positive urine drug test at screening; 5. Documented history of excessive consumption of alcohol (daily intake in excess of the equivalent of 40 g pure alcohol within 12 months before screening); 6. Documented history of excessive consumption of caffeine-containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc.); 7. Known intolerance/hypersensitivity to any of the excipients/components contained in the formulation used in the study (BDP or other corticosteroids, formoterol or other ? agonist); 8. History of asthma (including childhood asthma) peptic ulcer, glaucoma, ocular herpes simplex; 9. Relevant infectious disease within the past 2 months prior to screening or between screening and randomisation; 10. Any drug treatment (except of paracetamol, hormonal replacement and hormonal contraceptives) taken from 14 days (2 months for enzyme-inducing drugs, enzyme inhibiting drugs, 3 months for biologic drugs or any drug known to have a well defined potential for hepatotoxicity [e.g., isoniazide, nimesulide, ketoconazole]) prior to screening or between screening and randomisation, this including prescribed or over-the-counter (OTC) medicines, vitamins, homeopathic remedies, any traditional Chinese medicine etc.; 11. Blood donation or blood loss =400 mL within 3 months prior to screening or between screening and randomisation; 12. Participation in another clinical study with an investigational drug in the month preceding the administration of the study drug; 13. Positive test results for human immunodeficiency virus (HIV-1/2), hepatitis B (HB) or hepatitis C virus (HCV); 14. Unsuitable veins for repeated venipuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety assessments; | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital, Sichuan University
Outcome results
None listed