Patients with moderate to severe persistent asthma. MedDRA version: 9.1 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:
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy the following criteria before entering the study: - Male or female, aged between 18 and 65 years of age inclusive; - History of moderate to severe persistent asthma for at least 6 months prior to the screening visit; - Reversibility of at least 12% in FEV1 and 200 ml following inhalation of 400µg salbutamol at screening; - FEV1 more than or equal to 50% (upper limit 80%) of predicted at screening and baseline (prior to dosing with study medication); - Already treated with ICS at a stable daily dose =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe life-threatening asthma or hospitalization for an asthma exacerbation within 3 months prior to the screening visit and hospitalization for a related disorder (pneumothorax, bronchopneumonia, etc.) in the past 3 months before screening visit; - Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease; - Presence or history of any significant cardiac arrhythmia or diagnosed cardiac disease including coronary artery disease, congestive heart failure and uncontrolled hypertension; - Respiratory tract infection requiring treatment with antibiotics within 8 weeks prior to the screening visit; - Any significant respiratory disorder other than asthma; - Smokers of more than 10 cigarettes/day (or equivalent) or a smoking history of more than 10 pack years; - Pure seasonal asthma and/or a history of seasonal exacerbation of asthma; - Use of any of the prohibited medication as detailed in the concomitant medication section; - Participation in any other clinical trial within 2 months of the screening visit; - Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study; - Patients with any sensitivity or allergy to any of the products used within this clinical trial; - Patients with diabetes mellitus; - History of drug and/or alcohol abuse; - Incompliance to PEF tests and study medication (more than 20% of PEF tests or study medication intake missing) during the run-in period; - Patients with asthma exacerbations during the run-in period; - Patients with known history of hepatitis and/or AIDS or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the therapeutic efficacy in a non-inferiority model of 12 weeks course of SMB BUDESONIDE-SALMETEROL DPI capsule 150/25µg delivered by AXAHALER®, taken BID, versus SYMBICORT® TURBUHALER® 200/12µg BID, taken by inhalation, in patients with moderate to severe persistent asthma. ;Secondary Objective: - To compare the safety of SMB BUDESONIDE-SALMETEROL DPI capsule 150/25µg taken BID versus SYMBICORT® TURBUHALER® 200/12µg BID taken by inhalation, in patients with moderate to severe persistent asthma over 12 weeks.;Primary end point(s): Primary efficacy variable: - Mean change over the weeks from baseline to the final visit (week 12) in the morning pre-dose PEF Secondary efficacy variables (PFT will be performed at each visit before study drug intake at least 12h after the previous dose) : - Mean Change over the weeks from baseline to week 12 in evening pre-dose PEF - Mean Change over the weeks from baseline to week 12 in FEV1 - Mean Change over the weeks from baseline to week 12 in FEV1% of predicted - Mean Change over the weeks from baseline to week 12 in FVC - Asthma symptoms score (mean change over the weeks from baseline to week 12) - Sleep disturbance score (subset of the asthma symptom score) (mean change over the weeks from baseline to week 12) - Number of asthma exacerbations - Number of bronchodilator rescue inhalations Safety profile will be compared using: Adverse events, Physical examination, Vital signs, 12-lead ECG, Laboratory data, Withdrawals or drop-out rate due to Adverse Events . | — |
Countries
Bulgaria
Outcome results
None listed