A phase II, randomised, partially-blinded, cross over study to evaluate the systemic effect of two doses of the SMB BUDESONIDE-SALMETEROL DPI fixed-dose combination capsule (300/25 µg BID and 150/25 µg BID) delivered by the AXAHALER® versus PULMICORT® TURBOHALER® 400µg BID and SEREVENT® DISKUS® 50µg BID versus placebo in mild persistent asthmatic patients.
- Conditions
- Patients with a mild persistent asthmaMedDRA version: 12.1Level: LLTClassification code 10049106Term: Asthma chronic
- Registration Number
- EUCTR2010-020794-16-BG
- Lead Sponsor
- aboratoires SMB S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The study objectives are:<br>• 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.<br>;Secondary Objective: • To assess and compare the safety of the test versus reference products.<br>;Primary end point(s): Primary endpoint:<br>• Change from baseline in the AUC of 24-hour plasma cortisol (mean change from baseline to day 11 of each period).<br><br>Other safety parameters:<br>• Change from baseline in the Cmax of the 24-hour plasma cortisol (mean change from baseline to day 11 of each period).<br>• Change from baseline in the AUC of 24-hour urinary cortisol (mean change from baseline to day 11 of each period).<br>• Adverse events (including asthma exacerbations)<br>• Physical examination<br>• Vital signs<br>• Laboratory data<br>• 12-lead ECG data<br>• Withdrawals or drop-out rate
- Secondary Outcome Measures
Name Time Method