Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder

Asthmatic Clinical Trial

Official title:

A Phase II, Monocentric, Open, Randomized, 6-way Cross-over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate 100/6 mcg and 200 mcg) Administered With and Without Activated Charcoal in Adult Asthmatic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738087
• Other study ID #: CCD-1205-PR-0087
• Secondary ID: 2012-002370-30
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthmatic

Intervention

Drug:
• NEXThaler 100/6 mcg DPI

• Flixotide Accuhaler 500 mcg
Active comparator
• NEXThaler 200/6 mcg DPI

• NEXThaler placebo
Placebo comparator

Locations

Country	Name	City	State
United Kingdom	The Medicine Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma glucose	the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmax and tmax	from predose until 12 hours postdose
Other	Heart rate (HR)	the following parameters will be evaluated: HR AUC0-12/12h	from predose until 12 hours postdose
Other	Plasma cortisol	the following parameters will be evaluated: AUC0-24, Cmin and tmin	from predose until 24 hours postdose
Other	Plasma potassium	the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmin ad tmin	from predose until 12 hours postdose
Other	Systolic and Diastolic Blood Pressure (SBP and DBP)	the following parameters will be evaluated: SBP AUC0-12/12h and DBP AUC0-12/12h	from predose until 12 hours postdose
Primary	Formoterol AUC0-t and B17MP AUC0-t		from predose until 12 hr post dose
Secondary	BDP pharmacokinetic (PK) parameters	The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2	from predose until 12 hr post dose
Secondary	Other PK parameter of B17MP and formoterol	the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2	from predose until 12 hours postdose

External Links

•   CSR Synopsis available in the CHIESI Clinical Study Register
•   Study Record on EU Clinical Trials Register including results