A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
12–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
2. Written informed consent;
3. Diagnosis of asthma as defined in the GINA guidelines;
4. Patients with stable asthma, according to the Investigator's opinion;
5. Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
6. Patients with a forced expiratory volume in one second (FEV1) \> 70% of predicted values;
7. Patients with a peak inspiratory flow (PIF) \> 40 L/min
8. Reversibility test;
9. Non- or ex-smokers;
10. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;
You may not be if
1. Pregnant or lactating female;
2. Having received an investigational drug within 2 months before the screening visit
3. Diagnosis of COPD as defined by the current GOLD guidelines;
4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
5. Known hypersensitivity to the active treatments;
6. History of drug addiction or excessive use of alcohol;
7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
9. Inability to perform the required breathing technique and blood sampling;
10. Lower respiratory tract infection within 1 month prior to the screening visit;
11. Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.
Clareo Health | A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.
