Asthmatic
Conditions
Keywords
patients, Adult
Brief summary
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths. At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
Interventions
DRUGNEXThaler 100/6 mcg DPI
DRUGFlixotide Accuhaler 500 mcg
Active comparator
DRUGNEXThaler 200/6 mcg DPI
DRUGNEXThaler placebo
Placebo comparator
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011 * Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations. * Patients with Forced Expiratory Volume in 1 sec (FEV1) \>= 70 % of predicted values * Non or ex-smokers * Body Mass Index (BMI) \>= 18.5 and \<= 32 kg/m2
Exclusion criteria
* Pregnant or lactating women unless using acceptable methods of contraception * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) * History of near fatal asthma * Patients with abnormal QTcF at screening Visit * Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period. * Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period. * History of drug addiction or excessive use of alcohol ; * Diagnosis of restrictive lung disease. * Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids) * Significant medical history or any laboratory abnormality indicative of a significant underlying condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Formoterol AUC0-t and B17MP AUC0-t | from predose until 12 hr post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BDP pharmacokinetic (PK) parameters | from predose until 12 hr post dose | The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2 |
| Other PK parameter of B17MP and formoterol | from predose until 12 hours postdose | the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma potassium | from predose until 12 hours postdose | the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmin ad tmin |
| Plasma glucose | from predose until 12 hours postdose | the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmax and tmax |
| Systolic and Diastolic Blood Pressure (SBP and DBP) | from predose until 12 hours postdose | the following parameters will be evaluated: SBP AUC0-12/12h and DBP AUC0-12/12h |
| Heart rate (HR) | from predose until 12 hours postdose | the following parameters will be evaluated: HR AUC0-12/12h |
| Plasma cortisol | from predose until 24 hours postdose | the following parameters will be evaluated: AUC0-24, Cmin and tmin |
Countries
United Kingdom
Outcome results
None listed