Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NovaMed Pharmaceuticals Inc.
Age
12–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provision of informed consent by the subject and his/her legal guardian if the subject is under 18 years old.
Male or females aged more than 12 and under 70
Had a definite diagnosis of asthma with symptoms of cough/expectoration/chest tightness/wheeze/breathlessness within the last one month
Inhaled corticosteroid (ICS) naïve or no regular use of ICS within the last one month (It is suggested that ICS average daily dose with no more than 100mg budesonide or equal within the last month as "No-regular-use")
FEV1 between 60% and 85% of predicted normal values
Reversibility test of airway obstruction is positive, i.e. degree of reversibility in FEV1 as over 12%(included) and 200ml(included). Or average diurnal PEFR variability is not less than 20% in two weeks.
Are able to use Peak Flow Meter and record it on patient diary card
You may not be if
Asthma exacerbation leading to hospitalization for more than 2 days within the last 6 months or emergency room visit due to asthma exacerbation in the last 3 months prior to screening
Infection of respiratory system in the last 4 weeks prior to screening visit
Use of oral, injectable, rectal or transdermal glucocorticoid in the last 4 weeks prior to screening visit
Use of Leukotriene receptor antagonist (LTRAs), oral b2 agonist, methylxanthines or use of inhaled long acting b2 agonist, inhaled anticholinergic receptor in the last 1 week, or inhaled Tiotropium Bromide within 45 days prior to screening visit
Patients with chronic obstructive pulmonary disease (COPD)or COPD with asthma
Patients with severe persistent asthma (Based on definition in GINA 2006)
Patients with specific immunity treatment (including monoclonal antibody treatment) due to asthma within the 6 months prior to screening visit
Patients with eye disorders including cataract, glaucoma and herpes virus infection
Smoking history of 10 pack-year (1 pack-year refers to 20 cigarette per day for 1 year)
History of drug or alcohol abuse
History of adrenal disease
History of malignancy disease in the last 5 years, with the exception of basal cell carcinoma
Heart function failure or any severe systematic disease, at the investigator's discretion, which will make it undesirable for the patient to participate in the trial or which could jeopardize compliance with the trial protocol
ALT or AST \> 2 times of upper limit of reference range
Creatinine (Cr) \> 159µmol/L for males or \> 141µmol/L for females
Patients with hypersensitivity to budesonide and/or lactose
Participation in a clinical study or treatment with a non-approved experimental medication in the last 1 month
Pregnant or breast-feeding women, or women of childbearing age without appropriate contraception measures
Limitations:
The following medications are prohibited from screening onward:
Use of oral, injectable, rectal or transdermal glucocorticoid
