EUCTR2006-001514-33-EEActive, not recruitingNot Applicable
A phase III, randomized, parallel group study to compare the therapeutic efficacy of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25µg BID delivered by the AXAHALER® versus SERETIDE® DISKUS® 500/50µg (Fluticasone propionate 500µg/Salmeterol 50µg) BID over 12 weeks and to evaluate the safety of SMB BUDESONIDE-SALMETEROL 300/25µg over an additional period of 12 weeks in moderate to severe persistent asthmatic patients. - BUSA
aboratoires SMB S.A0 sites500 target enrollmentStarted: May 19, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1) Male or female, aged between 18 and 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) more than or equal to 50% (upper limit 80%) of predicted at screening and baseline (prior to dosing with study medication);
- •5) Able to comply with all study procedures, including the use of study inhalers, spirometer and peak flow meter;
- •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, as determined by the investigator and provide a negative blood and urine pregnancy test at the screening visit and a negative urine dipstick pregnancy test at the randomisation visit.
- •Are the trial subjects under 18?
- •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
- •(pneumothorax, bronchopneumonia, etc.) 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
- •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.
Investigators
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