Status:
COMPLETED
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief 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, i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01848769
Start Date
September 1 2009
End Date
December 1 2010
Last Update
July 31 2020
Active Locations (1)
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1
BorneAstmaKlinikken
Copenhagen, Denmark, 2100