Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
Phase 2
Completed
- Conditions
- Asthmatic
- Interventions
- Drug: NEXThaler 200/6 mcg DPIDrug: NEXThaler placeboDrug: NEXThaler 100/6 mcg DPI
- Registration Number
- NCT01738087
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Flixotide Accuhaler 500 mcg Flixotide Accuhaler 500 mcg Single dose (2 inhalations) of fluticasone propionate NEXThaler 200/6 mcg DPI NEXThaler 200/6 mcg DPI Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg NEXThaler placebo NEXThaler placebo Single dose (4 inhalations) NEXThaler 100/6 mcg plus CB NEXThaler 100/6 mcg DPI Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg NEXThaler 100/6 mcg DPI NEXThaler 100/6 mcg DPI Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg NEXThaler 200/6 mcg plus CB NEXThaler 200/6 mcg DPI Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg
- Primary Outcome Measures
Name Time Method Formoterol AUC0-t and B17MP AUC0-t from predose until 12 hr post dose
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
The Medicine Evaluation Unit
🇬🇧Manchester, United Kingdom