Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old

Study Identifier:
CCD-1103-PR-0058
ClinicalTrials.gov Identifier:
NCT01468272
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: free comb. beclomethasone DPI and formoterol DPI
  • Drug: CHF 1535 50/6 NEXT DPI
Date
Nov 2011 - Aug 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 5 - 11 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male/Female children aged 5 -11y
  • Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
  • Children with stable asthma
  • Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
  • Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment.
  • A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.
Exclusion Criteria
  • Past or present diagnoses of cardiovascular, renal or liver disease
  • Known hypersensitivity to the active treatments
  • Exacerbation of asthma symptoms within the previous 4 weeks
  • Inability to perform the required breathing technique and blood sampling
  • Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
  • Lower respiratory tract infection within 1 month prior to screening (visit 1)
  • Disease (other than asthma) which might influence the outcome of the study
  • Obesity, i.e. \> 97% weight percentile by local standards
Healthy Volunteers
No

Protocol Summary

This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Study Locations

Location
Status
Location
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Copenhagen, Denmark, 2100
Status
N/A

Study Publications

Chawes BL, Govoni M, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilsson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Piccinno A, Sergio F, Ciurlia G, Poli G, Acerbi D, Singh D, Bisgaard H. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014 Aug;108(8):1108-16. doi: 10.1016/j.rmed.2014.05.007. Epub 2014 Jun 17.