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.

Asthma Clinical Trial

— ADONE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191424
• Other study ID #: CCD-1017-PR-0034
• Secondary ID: 2010-018947-33
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF1535 NEXT DPI
FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
• BDP DPI and formoterol DPI
FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

References & Publications (2)

Chawes BL, Govoni M, Piccinno A, Kreiner-Møller 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 an — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma AUC0-t for B17MP	0-8hrs
Secondary	Different pharmacokinetic parameters	BDP/B17MP and FF PK parameters	0-8hrs
Secondary	Lung function parameters	Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).	0-8hrs
Secondary	Plasma potassium	Plasma Potassium Cmin, tmin and AUC0-t	0-8hrs
Secondary	Plasma glucose	Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t	0-8hrs
Secondary	Heart rate	time averaged value (AUC0-t/8)	0-8hrs
Secondary	Adverse Events		during the whole study period

External Links

•   Study Record on EU Clinical Trials Register including results