A Phase 2 interventional study of NEXThaler 100/6 mcg DPI and Flixotide Accuhaler 500 mcg in Asthmatic, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Chiesi Farmaceutici S.p.A. · Phase 2, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg
Drug: NEXThaler 100/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg
Drug: NEXThaler 200/6 mcg DPI
Single dose (4 inhalations)
Drug: NEXThaler placebo
Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg
Drug: NEXThaler 100/6 mcg DPI
Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg
Drug: NEXThaler 200/6 mcg DPI
Single dose (2 inhalations) of fluticasone propionate
Drug: Flixotide Accuhaler 500 mcg
Also known as: Fixed combination of BDP plus formoterol fumarate
Active comparator
Also known as: Fluticasone Propionate
Also known as: Fixed combination of BDP plus formoterol fumarate
Placebo comparator
Formoterol AUC0-t and B17MP AUC0-t
Time frame: from predose until 12 hr post dose
BDP pharmacokinetic (PK) parameters
The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2
Time frame: from predose until 12 hr post dose
Other PK parameter of B17MP and formoterol
the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2
Time frame: from predose until 12 hours postdose
Plasma glucose
the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmax and tmax
Time frame: from predose until 12 hours postdose
Heart rate (HR)
the following parameters will be evaluated: HR AUC0-12/12h
Time frame: from predose until 12 hours postdose
Plasma cortisol
the following parameters will be evaluated: AUC0-24, Cmin and tmin
Time frame: from predose until 24 hours postdose
Plasma potassium
the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmin ad tmin
Time frame: from predose until 12 hours postdose
Systolic and Diastolic Blood Pressure (SBP and DBP)
the following parameters will be evaluated: SBP AUC0-12/12h and DBP AUC0-12/12h
Time frame: from predose until 12 hours postdose
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Chiesi Farmaceutici S.p.A.