Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

Study Identifier:
CCD-0902-PR-0013
ClinicalTrials.gov Identifier:
NCT01848769
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: CHF1535 pMDI + AC Plus
  • Drug: BDP + AC Plus
  • Drug: Formoterol + AC Plus
Date
Sep 2009 - Dec 2010
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 5-11 years
  • 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 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-agonist treatment for a minimum of 4 h prior to each dose period.
  • 6\. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device 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 inclusion
  • Lower respiratory tract infection within 1 month prior to inclusion
  • 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

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).

Study Locations

Location
Status
Location
BorneAstmaKlinikken
Copenhagen, Denmark, 2100
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, Piccinno A, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013 Apr;75(4):1081-8. doi: 10.1111/j.1365-2125.2012.04459.x.