Diagnosis of moderate to severe persistent asthma MedDRA version: 8.0 Level: PT Classification code 10003553
Conditions
Interventions
Product Name: Budesonide-Salmeterol
Product Code: BUSAL
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration
Sponsors
Laboratories SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female, 18-70 years of age inclusive; 2) History of moderate to severe persistent asthma for at least 3 months prior to the screening visit; 3) Reversibility of at least 12% in FEV1 , following inhalation of 400 µg salbutamol at screening and baseline; 4) FEV1 (in each of three consecutive measures) 50%-80% of predicted at screening and baseline (prior to dosing with study medication); 5) Able to comply with all study procedures; 6) Willing to withhold the use of short acting beta-agonists for at least 6 hours prior to each clinic visit; 7) Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form; 8) If the patient is female and of childbearing potential, she must be using an efficient means of birth control and provide a negative pregnancy test at the screening visit and randomisation 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: 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 in the past 3 months before screening visit; 2) Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease; 3) 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); 4) Respiratory tract infection requiring treatment with antibiotics within 8 weeks prior to the screening visit; 5) Any significant respiratory disorder other than asthma; 6) Smokers of more than 10 cigarettes/day (or equivalent) or a smoking history of more than 10 pack years; 7) Pure seasonal asthma and/or a history of seasonal exacerbation of asthma; 8) Use of any of the prohibited medication as detailed in the concomitant medication section; 9) Participation in any other clinical trial within 3 months of the screening visit; 10) Participation in any other clinical trial with SMB BUDESONIDE-SALMETEROL DPI; 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) Patients with diabetes mellitus; 14) History of drug and/or alcohol abuse. 15) Incompliance to PEF tests and study medication (more than 20% of PEF tests or study medication intake missing) during the run-in period; 16) Patients who received oral or parenteral steroids in the preceding 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the therapeutic efficacy, in a non-inferiority model, of 12 weeks course of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg, taken BID, versus SERETIDE® DISKUS® 500/50µg BID, taken by inhalation, in patients with moderate to severe persistent asthma.;Secondary Objective: The secondary objective is to evaluate the safety of a 24 weeks course of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg BID, taken by inhalation, in patients with moderate to severe persistent asthma AND to compare the safety of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg BID taken by inhalation versus SERETIDE® DISKUS® 500/50µg BID taken by inhalation in patients with moderate to severe persistent asthma over 12 weeks.;Primary end point(s): Mean change over the week 0 to 12 in morning PEF is the primary end-point of the study. | — |
Countries
Estonia, Finland
Outcome results
None listed