Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI

Inclusion criteria

• Male and female adults (≥18 and ≤ 70 years old).
• Written informed consent obtained by the patient prior to any study-related procedures.
• Diagnosis of asthma as defined by the GINA guidelines, update 2009, at least in the 6 months before the screening visit.
• Asthmatic patients already treated with low or medium daily dose of ICS (e.g. BDP or equivalent ≤ 1000 µg/die) or low dose of ICS/LABA fixed combination (e.g. salmeterol/fluticasone 100/500 µg/die).
• Patients with a pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 60% and ≤ 90% of the predicted values.
• Non or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year. (Pack/year: number of cigarette smoked per day multiplied by the number of years of smoking/20).
• Ability to a proper use of pMDI plus spacer and DPI devices.
• A cooperative attitude to be compliant with study procedures.
• Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2

Exclusion criteria

• 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 or are using one or more of the following acceptable methods of contraception.

• surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
• hormonal contraception (implantable, patch, oral)
• 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 cream/foam/gel/ suppository.
• Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
• History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
• Patients with abnormal QTcF at Screening Visit: QTcF > 450 msec for male subjects and QTcF > 470 msec for female subjects.
• Diagnosis of COPD as defined by the current GOLD guidelines, updates 2009.
• Hospitalization due to asthma exacerbation within 1 month prior to the screening visit or during the run-in period.
• Lower respiratory tract infection within one month prior to screening until randomization.
• History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
• History 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) or psychological or other emotional problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements;
• Diagnosis of restrictive lung disease.
• Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids).
• Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
• Having received an investigational drug within 1 month before the screening visit.
• 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.
• 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.