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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) parameters

Other 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

Page last updated: August 23, 2015

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