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.

NCT01191424 | Completed Phase 2

• 2 other identifiers: CCD-1017-PR-00342010-018947-33
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 2

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.

Conditions

Asthma

Keywords

Asthma; PK; Adolescents; Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Different pharmacokinetic parameters

  0-8hrs

• Lung function parameters

  0-8hrs

• Plasma potassium

  0-8hrs

• Plasma glucose

  0-8hrs

• Heart rate

  0-8hrs

Study Arms (2)

CHF1535 NEXT DPI

EXPERIMENTAL

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

Drug: CHF1535 NEXT DPI

Free combination BDP and FF

ACTIVE COMPARATOR

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

Drug: BDP DPI and formoterol DPI

Interventions

CHF1535 NEXT DPI DRUG

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

CHF1535 NEXT DPI

BDP DPI and formoterol DPI DRUG

FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

Free combination BDP and FF

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (2)

Copenhagen University Hospital

Copenhagen, 2800, Denmark

Location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24746942 BACKGROUND

• 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.

  PMID: 24830339 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dave Singh, MD

  Medicines Evaluation Unit

  STUDY DIRECTOR

• Hans Bisgaard, MD

  Copenhagen University Hospital at Herlev

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

DK (1); GB (1)