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This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally compared to the systemic exposure in adults without the spacer device.
Full description
The proposed clinical pharmacology study is aimed to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI (to reach a total dose of BDP 400 µg and formoterol 24 µg) with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products (to reach the same total dose of BDP and formoterol) in adolescent asthmatic patients. The systemic exposure to BDP/B17MP and formoterol after inhalation of CHF 1535 pMDI in adolescents will be additionally compared to the systemic exposure in adults without the spacer device.
The chosen doses correspond to the maximum daily dose of the two components administered as fixed combination.
Enrollment
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Inclusion and exclusion criteria
Patients will be enrolled if they meet all of the following criteria:
Male and female adolescents, aged ≥ 12 and < 18 years at the time of Screening Visit or male and female adults, aged ≥ 18 and ≤ 65 years at the time of Screening Visit.
Written informed consent obtained by the patient in case of adult patients and by parents/legal representative and by the minor (according to local regulation).
A diagnosis of asthma as defined in the GINA guidelines (updated 2010) 6 months before the screening visit.
Male/female adolescent and adult patients with asthma stable enough, according to GINA guidelines (updated 2010) and based on the Investigator's opinion, to allow a wash out period from inhaled BDP of 2 days before each single day study treatments and any ICS other than BDP of 1 day before each single day study treatments.
Male/female adolescents and adults asthmatic patients already treated with ICS or ICS/long-acting inhaled β2-agonists or using short-acting inhaled β2-agonists as reliever to control asthma symptoms.
Adolescents and adults with a forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred) after withholding short acting β2-agonist treatment for a minimum of 6 h prior to screening or 24 hours in case of long acting β2-agonist.
Non- or ex-smokers who smoked less than 5 pack-years (e.g. < 20 cigarettes per day for 5 years) and stopped smoking for at least 1 year.
A cooperative attitude and ability to be trained about the proper use of pMDI with and without a spacer device and compliant to study procedures.
Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2
Patients will not be enrolled if one or more of the following criteria are present:
Primary purpose
Allocation
Interventional model
Masking
60 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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