Moderate to severe symptomatic asthmatic patients aged = 12 years under treatment with inhaled corticosteroids (< 2000 µg BDP or equivalent). MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
CHIESI Farmaceutici S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the patient and/or the parents/legal representatives (according to the local laws) 2. Outpatients of both sexes, aged = 12 years 3. Clinical diagnosis of moderate to severe symptomatic asthma treated with a stable daily dose of inhaled corticosteroids 40% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urinary ß-HCG laboratory test (> 5 IU/ml) 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: •12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml •or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy •or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). For females aged 12 to 17 years acceptable methods of contraception may include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation. 3. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer; 4. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit); 5. Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit; 6. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (updated 2006); 7. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency; 8. Diagnosis of restrictive lung disease 9. Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids); 10. Intolerance or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids; 11. Allergy to any component of the study treatments; 12. Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit; 13. Having received an investigational drug within 2 months before the screening visit; 14. Inability to comply with study procedures or treatment; 15. Significant medical history of 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; 16. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable. 17. Patients with abnormal QTc at screening visit (> 450 msec-Bazett formula).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that CHF 1535 via NEXT™DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 µg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a “extrafine” pMDI in terms of pulmonary function (change from baseline in pre-dose morning FEV1) in moderate to severe symptomatic asthmatic patients aged = 12 years under treatment with inhaled corticosteroids (< 2000 µg BDP or equivalent). ;Secondary Objective: • To show that CHF 1535 via NEXT™ DPI and CHF 1535 via HFA-134a “extrafine” pMDI 2 inhalations twice daily are superior to the corresponding CHF 1535 via NEXT™ DPI and CHF 1535 via HFA-134a “extrafine” pMDI 1 inhalation twice daily in terms of pre dose morning FEV1. • To evaluate the effect of the CHF 1535 via NEXT™ DPI compared to CHF 1535 via HFA-134a “extrafine” pMDI on other lung function parameters, on clinical outcome measures, on safety and tolerability ;Primary end point(s): Change from baseline measured at clinic visit V2 (end of run-in) to the end of treatment period (V5) in pre-dose morning FEV1 (L) measured at clinic. | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary
Outcome results
None listed