Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old
- Conditions
- Asthma
- Interventions
- Drug: CHF 1535 35/4µg NEXThaler®
- Registration Number
- NCT02787967
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI
- Detailed Description
This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
- Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.
- Age ≥ 5 < 12 years (8 to 10 children in the age range 5-8 years old).
- Children with a forced expiratory volume in one second (FEV1)>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.
- A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures
- Past or present diagnosis of cardiovascular, renal or liver disease.
- Known hypersensitivity to the active treatmen
- Exacerbation of asthma symptoms within 4 weeks prior to screening.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NEXThaler® 35/4µg CHF 1535 35/4µg NEXThaler® CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg Reference treatment free comb. beclomethasone DPI and formoterol DPI Drug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
- Primary Outcome Measures
Name Time Method Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP predose, 15,30min, 1,2,4,6,8 hours post dose B17MP: Profile of Pharmacokinetics
- Secondary Outcome Measures
Name Time Method Formoterol T1/2 predose, 15min, 30 min, 1,2,4,6,8 hours postdose Formoterol: profile of pharmacokinetics
BDP Cmax predose, 15min,30min,1,2,4,6,8 hours post dose BDP: profile of pharmacokinetics
BDP Tmax predose, 15min,30min,1,2,4,6,8 hours post dose BDP: profile of pharmacokinetics
BDP T1/2 predose, 15min,30min,1,2,4,6,8 hours post dose BDP: profile of pharmacokinetics
B17MP Cmax predose, 15min,30min,1,2,4,6,8 hours post dose 17MP: profile of pharmacokinetics
Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [ predose, 15min, 30 min, 1,2,4,6,8 hours postdose Formoterol: profile of pharmacokinetics
Formoterol Tmax predose, 15min, 30 min, 1,2,4,6,8 hours postdose Formoterol: profile of pharmacokinetics
plasma potassium Area Under Curve (AUC) predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose plasma potassium to evaluate drug systemic effect
B17MP Tmax predose, 15min,30min,1,2,4,6,8 hours post dose BDP: profile of pharmacokinetics
BDP Area Under Curve (AUC) predose, 15min,30min,1,2,4,6,8 hours post dose BDP: profile of Pharmacokinetics
Formoterol Cmax predose, 15min, 30 min, 1,2,4,6,8 hours postdose Formoterol: profile of pharmacokinetics
plasma potassium Tmin predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose plasma potassium to evaluate drug systemic effect
Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat). from predose up to 8 hours postdose Urinary cortisol to evaluate drug systemic effect
B17MP T1/2 predose, 15min,30min,1,2,4,6,8 hours post dose BDP: profile of pharmacokinetics
plasma potassium Cmin predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose plasma potassium to evaluate drug systemic effect
Trial Locations
- Locations (1)
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
🇩🇰Copenaghen, Denmark