ASTHMA MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: CHF 1535 100/6 NEXT DPI®
Product Code: CHF 1535 100/6 NEXT DPI®
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Beclomethasone Dipropionate
CAS Number: 5534-09-8
Other descri
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults (=18 years old). 2. Written informed consent obtained by the patient prior to any study-related procedures. 3. Diagnosis of asthma as defined in the GINA guidelines, update 2009 at least in the 6 months before the screening visit. 4. A documented positive response to the reversibility test (within the last 6 months) defined as ?FEV1 = 12% and = 200 mL over baseline, 30 minutes after 400 µg salbutamol pMDI (ATS/ERS taskforce 2005). In case the patient doesn’t have any documented reversibility test, this test will be performed at the screening. 5. Patients with a forced expiratory volume in one second (FEV1) > 80% of the predicted values following adequate wash-out from bronchodilators. 6. Asthma Control Questionnaire (ACQ) score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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 6 months of spontaneous amenorrhea with already documented serum FSH levels > 40 mIU/mL or are using one or more of the following acceptable methods of contraception. a. surgical sterilization (e.g. bilateral tubal ligation, hysterectomy) b. hormonal contraception (implantable, patch, oral) c. double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) A urinary pregnancy test will be performed at screening and at the last visit in women of childbearing potential. 2. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer. 3. History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit). 4. Diagnosis of COPD as defined by the current GOLD guidelines, updates 2009. 5. Hospitalization due to asthma exacerbation within 1 month prior to the screening visit or moderate/severe asthma exacerbation during the run-in period. 6. Lower respiratory tract infection within 1 month prior to the screening visit. 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 before the screening visit (3 months for parenteral depot corticosteroids). 10. Intolerance or contra-indication to treatment with ?2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments. 11. Having received an investigational drug within 1 month before the screening visit. 12. 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. 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 µg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients = 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 µg) 1 inhalation bid.;Secondary Objective: To evaluate the superiority of CHF 1535 100/6 µg NEXT DPI®, 1 inhalation twice daily, over marketed beclomethasone DPI 100 µg, 1 inhalation twice daily, in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF). To evaluate the effect of CHF 1535 100/6 µg NEXT DPI® on other lung function parameters and on clinical outcome measures, and the safety and tolerability. ;Primary end point(s): Change from baseline to the entire treatment period in average pre-dose morning PEF | — |
Countries
Bulgaria, Germany, Hungary
Outcome results
None listed