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.

Study Identifier:
CCD-1017-PR-0034
ClinicalTrials.gov Identifier:
NCT01191424
EudraCT Identifier:
2010-018947-33
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF1535 NEXT DPI
  • Drug: BDP DPI and formoterol DPI
Date
Oct 2010 - Sep 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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.
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Copenhagen University Hospital
Copenhagen, Denmark, 2800
Status
N/A
Location
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Status
N/A

Study Publications

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.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.