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

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthmatic

Treatments: Drug: Flixotide Accuhaler 500 mcg; Drug: NEXThaler 200/6 mcg DPI; Drug: NEXThaler 100/6 mcg DPI; Drug: NEXThaler placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01738087

CCD-1205-PR-0087

2012-002370-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups, including a placebo group

NEXThaler 100/6 mcg DPI

Experimental group

Description:

Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg

Treatment:

Drug: NEXThaler 100/6 mcg DPI

NEXThaler 200/6 mcg DPI

Experimental group

Description:

Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg

Treatment:

Drug: NEXThaler 200/6 mcg DPI

NEXThaler placebo

Placebo Comparator group

Description:

Single dose (4 inhalations)

Treatment:

Drug: NEXThaler placebo

NEXThaler 100/6 mcg plus CB

Experimental group

Description:

Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg

Treatment:

Drug: NEXThaler 100/6 mcg DPI

NEXThaler 200/6 mcg plus CB

Experimental group

Description:

Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg

Treatment:

Drug: NEXThaler 200/6 mcg DPI

Flixotide Accuhaler 500 mcg

Active Comparator group

Description:

Single dose (2 inhalations) of fluticasone propionate

Treatment:

Drug: Flixotide Accuhaler 500 mcg