A phase III, randomized, parallel group study to compare the therapeutic efficacyof SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg BID delivered bythe AXAHALER® versus SERETIDE® DISKUS® 500/50µg (Fluticasonepropionate 500µg/Salmeterol 50µg) BID over 12 weeks and to evaluate the safety ofSMB BUDESONIDE-SALMETEROL 300/25µg over an additional period of 12weeks in moderate to severe persistent asthmatic patients. - BUSA

• Conditions: Diagnosis of moderate to severe persistent asthma; MedDRA version: 8.0Level: PTClassification code 10003553

• Registration Number: EUCTR2006-001514-33-FI
• Lead Sponsor: aboratories SMB S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>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 <br>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.