Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
Information source: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthmatic
Intervention: NEXThaler 100/6 mcg DPI (Drug); Flixotide Accuhaler 500 mcg (Drug); NEXThaler 200/6 mcg DPI (Drug); NEXThaler placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Chiesi Farmaceutici S.p.A.
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Formoterol AUC0-t and B17MP AUC0-t
Secondary outcome: BDP pharmacokinetic (PK) parametersOther PK parameter of B17MP and formoterol
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
The Medicine Evaluation Unit, Manchester M23 9QZ, United Kingdom
Additional Information
Starting date: November 2012
Last updated: January 29, 2013
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