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 Asthmati

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate

Criteria

Main Inclusion Criteria:

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;

Main Exclusion Criteria:

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.