Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Clenil Modulite
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 08/09/5534
Concentration unit: µg microgram(s)
Concentrati
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient’s written informed consent obtained prior to any study-related procedures. 2. Male or female patients aged 18-65 years included. 3. Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening. 4. Patients already treated with a dose of BDP or equivalent (according to GINA guidelines 2009) up to 2000 µg/day. 5. FEV1 = 60% of predicted patient’s normal value (after appropriate wash-out from bronchodilators) at screening and randomisation. 6. A documented positive response to the reversibility test, defined as an improvement in FEV1 of at least 12% from baseline value and 200 mL 20 to 30 minutes after 4 puffs of inhaled salbutamol pMDI (400 µg) at screening or within a year prior to screening and/or a documented (within 6 months prior to screening) hyper-responsiveness to methacholine on bronchial challenge testing (PC20 equal or less than 16 µg/ml). 7. Body weight resulting in a Body Mass Index (BMI) between 18.0 and 32 kg/m2 8. Non- or ex-smokers who smoked 1 year. 9. Electrocardiogram (12 lead) considered as normal (with QTcB = 450 ms for male and = 470 ms for female). 10. A co-operative attitude and ability to be trained about the proper use of pMDIs with spacers. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients incapable of giving consent personally, or mentally/legally incapacitated. 2. Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or are using one or more of the following highly effective and acceptable methods of contraception: a. surgical sterilization (e.g. bilateral tubal ligation, hysterectomy) b. hormonal contraception (implantable, injectable, patch, oral) c. other forms of effective contraception including placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository. A urine pregnancy test will be done at screening for women of childbearing potential and women who had a tubal ligation. 3. Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit. 4. Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation. 5. Lower respiratory tract infection within one month prior to screening until randomisation. 6. Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines. 7. Inability to carry out pulmonary function testing, the required breathing technique and/or repeated blood samplings. 8. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the Investigator’s opinion. 9. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening. 10. Any enzyme inducing or inhibiting drug (from 8 weeks before screening visit). 11. Allergy, sensitivity or intolerance to study drugs or excipients. 12. History or presence of drug addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc). 13. Patients who received any investigational new drug within the last 8 weeks before the screening. The patients cannot participate in another clinical study at the same time as the present study. 14. Blood donation (450 mL or more) or significant blood loss less than 12 weeks before the first intake of study drug. 15. Patients unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without and with charcoal block. ;Secondary Objective: • To evaluate the pharmacokinetic profile of BDP and additional PK parameters of B17MP after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ or the volumatic™ spacer devices at steady-state without and with charcoal block • To evaluate the general safety and the tolerability profile after repeated treatment;Primary end point(s): Determination of BDP/B17MP in EDTA human plasma: AUC 0-12h,ss and Cmax,ss, after inhalation of BDP | — |
Countries
United Kingdom
Outcome results
None listed