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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. (ADONE)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CHF1535 NEXT DPI

BDP DPI and formoterol DPI

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, PK, Adolescents, Adults

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
Written informed consent;
Diagnosis of asthma as defined in the GINA guidelines;
Patients with stable asthma, according to the Investigator's opinion;
Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;
Patients with a peak inspiratory flow (PIF) > 40 L/min
Reversibility test;
Non- or ex-smokers;
A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;

Main Exclusion Criteria:

Pregnant or lactating female;
Having received an investigational drug within 2 months before the screening visit
Diagnosis of COPD as defined by the current GOLD guidelines;
Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
Known hypersensitivity to the active treatments;
History of drug addiction or excessive use of alcohol;
Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
Inability to perform the required breathing technique and blood sampling;
Lower respiratory tract infection within 1 month prior to the screening visit;
Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.

Sites / Locations

Copenhagen University Hospital
Medicines Evaluation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF1535 NEXT DPI

Free combination BDP and FF

Arm Description

Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI

Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Different pharmacokinetic parameters

BDP/B17MP and FF PK parameters

Lung function parameters

Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).

Plasma potassium

Plasma Potassium Cmin, tmin and AUC0-t

Plasma glucose

Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t

Heart rate

time averaged value (AUC0-t/8)

Adverse Events

Full Information

NCT ID

NCT01191424

First Posted

August 27, 2010

Last Updated

July 30, 2020

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01191424

Brief Title

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.

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, PK, Adolescents, Adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHF1535 NEXT DPI

Arm Type

Experimental

Arm Description

Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI

Arm Title

Free combination BDP and FF

Arm Type

Active Comparator

Arm Description

Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF

Intervention Type

Drug

Intervention Name(s)

CHF1535 NEXT DPI

Intervention Description

FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER

Intervention Type

Drug

Intervention Name(s)

BDP DPI and formoterol DPI

Intervention Description

FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Primary Outcome Measure Information:

Title

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

Description

Plasma AUC0-t for B17MP

Time Frame

0-8hrs

Secondary Outcome Measure Information:

Title

Different pharmacokinetic parameters

Description

BDP/B17MP and FF PK parameters

Time Frame

0-8hrs

Title

Lung function parameters

Description

Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).

Time Frame

0-8hrs

Title

Plasma potassium

Description

Plasma Potassium Cmin, tmin and AUC0-t

Time Frame

0-8hrs

Title

Plasma glucose

Description

Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t

Time Frame

0-8hrs

Title

Heart rate

Description

time averaged value (AUC0-t/8)

Time Frame

0-8hrs

Title

Adverse Events

Time Frame

during the whole study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old) Written informed consent; Diagnosis of asthma as defined in the GINA guidelines; Patients with stable asthma, according to the Investigator's opinion; Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms; Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values; Patients with a peak inspiratory flow (PIF) > 40 L/min Reversibility test; Non- or ex-smokers; A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures; Main Exclusion Criteria: Pregnant or lactating female; Having received an investigational drug within 2 months before the screening visit Diagnosis of COPD as defined by the current GOLD guidelines; Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality; Known hypersensitivity to the active treatments; History of drug addiction or excessive use of alcohol; Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening; Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit; Inability to perform the required breathing technique and blood sampling; Lower respiratory tract infection within 1 month prior to the screening visit; Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dave Singh, MD

Organizational Affiliation

Medicines Evaluation Unit

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hans Bisgaard, MD

Organizational Affiliation

Copenhagen University Hospital at Herlev

Official's Role

Study Director

Facility Information:

Facility Name

Copenhagen University Hospital

City

Copenhagen

ZIP/Postal Code

2800

Country

Denmark

Facility Name

Medicines Evaluation Unit

City

Manchester

ZIP/Postal Code

M23 9QZ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24746942

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.

Results Reference

background

PubMed Identifier

24830339

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.

Results Reference

result

Links:

URL

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-018947-33

Description

Study Record on EU Clinical Trials Register including results

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