Clinical trial NCT01191424: 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.
Official title: A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
PK
Adolescents
Adults
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 57
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI
timeFrame: 0-8hrs
Secondary outcomes:
measure: Different pharmacokinetic parameters
timeFrame: 0-8hrs
measure: Lung function parameters
timeFrame: 0-8hrs
measure: Plasma potassium
timeFrame: 0-8hrs
measure: Plasma glucose
timeFrame: 0-8hrs
measure: Heart rate
timeFrame: 0-8hrs
measure: Adverse Events
timeFrame: during the whole study period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Medicines Evaluation Unit
name: Dave Singh, MD
role: STUDY_DIRECTOR
affiliation: Copenhagen University Hospital at Herlev
name: Hans Bisgaard, MD
role: STUDY_DIRECTOR
References:
citation: Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.
citation: Chawes BL, Govoni M, Piccinno A, Kreiner-Moller E, Vissing NH, Mortensen L, Nilsson E, Bisgaard A, Deleuran M, Skytt N, Samandari N, Acerbi D, Bisgaard H. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014 Nov;78(5):1169-71. doi: 10.1111/bcp.12424. No abstract available.