Status:
COMPLETED
Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma in Children
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief 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...
Detailed Description
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry pow...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01468272
Start Date
November 1 2011
End Date
August 1 2012
Last Update
July 31 2020
Active Locations (1)
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1
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Copenhagen, Denmark, 2100