Patients with a mild persistent asthma MedDRA version: 12.1 Level: LLT Classification code 10049106 Term: Asthma chronic
Conditions
Interventions
Product Name: SMB BUDESONIDE-SALMETEROL DPI 150/25µg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration unit: µg microgram(s)
Concentration type: e
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy the following criteria before entering the study: 1) Male or female, aged between 18 and 70 years of age inclusive at screening; 2) Documented history of mild persistent asthma for at least 3 months prior to the screening visit; 3) Reversibility of at least 12% in FEV1 and 200 mL, following inhalation of 400 µg salbutamol at screening; 4) FEV1 more than or equal to 80% of predicted at screening (prior to dosing with study medication); 5) Inhaled, oral, rectal and IV corticosteroid naïve asthmatic patients for at least 3 months before the screening visit; 6) Able to comply with all study procedures, including the use of study inhalers and spirometer; 7) Willing to withhold the use of short acting ß-agonists for at least 6 hours prior to the screening visit; 8) Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form; 9) If the patient is female and of childbearing potential, she must be using an efficient means of birth control, as determined by the investigator and provide a negative blood pregnancy test at the screening visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participating in the study: 1) Severe, life-threatening asthma or hospitalisation for an asthma exacerbation within 3 months prior to the screening visit and hospitalisation for a related disorder (pneumothorax, bronchopneumonia etc) in the past 3 months; 2) Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease; 3) Known history of HPA (hypothalamic-pituitary-adrenal) axis disease or malfunctioning; 4) Presence or history of any significant cardiac arrhythmia or diagnosed cardiac disease including coronary artery disease, congestive heart failure and uncontrolled hypertension (defined as having a diastolic blood pressure of 95 mmHg or above or a systolic blood pressure of 140 mmHg or above); 5) Respiratory tract infection requiring treatment with antibiotics within 8 weeks prior to the screening visit; 6) Any significant respiratory disorder other than asthma; 7) Smokers of more than 10 cigarettes/day (or equivalent) or a smoking history of more than 10 pack years; 8) Pure seasonal asthma and/ or a history of seasonal exacerbation of asthma; 9) Use of any of the prohibited medication as detailed in the concomitant medication section; 10) Participation in any other clinical trial within 2 months of the screening visit; 11) Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study; 12) Patients with any sensitivity or allergy to any of the products used within this clinical trial; 13) Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab); 14) History of drug and/ or alcohol abuse; 15) Breast-feeding or pregnant women; 16) Patients with diabetes mellitus; 17) Blood donation within 2 months of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objectives are: • To compare the systemic effect of two doses of SMB BUDESONIDE-SALMETEROL DPI capsule (300/25µg BID and 150/25µg BID) versus PULMICORT® TURBOHALER® 400µg BID and SEREVENT® DISKUS® 50µg BID versus placebo by the measurement of 24-hour plasma and urinary cortisol. ;Secondary Objective: • To assess and compare the safety of the test versus reference products. ;Primary end point(s): Primary endpoint: • Change from baseline in the AUC of 24-hour plasma cortisol (mean change from baseline to day 11 of each period). Other safety parameters: • Change from baseline in the Cmax of the 24-hour plasma cortisol (mean change from baseline to day 11 of each period). • Change from baseline in the AUC of 24-hour urinary cortisol (mean change from baseline to day 11 of each period). • Adverse events (including asthma exacerbations) • Physical examination • Vital signs • Laboratory data • 12-lead ECG data • Withdrawals or drop-out rate | — |
Countries
Bulgaria
Outcome results
None listed