Study Title: A Single-dose, Open-label, Randomised, 2-way Crossover, Clinical Pharmacology Study of Four Inhalations of CHF 1535 100/6 NEXT DPI® (Fixed Combination of Beclomethasone Diproponate 100 µg Plus Formoterol Fumarate 6 µg) Versus the Same Dose of CHF 1535 100/6 pMDI Both Administered With Charcoal Block.

Chiesi Farmaceutici S.p.A.1 site in 1 country24 target enrollmentMay 2011

ConditionsAsthma

DrugsBDP/Formoterol

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 24
Locations: 1
Primary Endpoint: lung bioavailability
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device. To determine lung exposure, the treatments are administered with charcoal block.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

June 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chiesi Farmaceutici S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female adults (≥18 and ≤ 70 years old).
•Written informed consent obtained by the patient prior to any study-related procedures.
•Diagnosis of asthma as defined by the GINA guidelines, update 2009, at least in the 6 months before the screening visit.
•Asthmatic patients already treated with low or medium daily dose of ICS (e.g. BDP or equivalent ≤ 1000 µg/die) or low dose of ICS/LABA fixed combination (e.g. salmeterol/fluticasone 100/500 µg/die).
•Patients with a pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 60% and ≤ 90% of the predicted values.
•Non or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year. (Pack/year: number of cigarette smoked per day multiplied by the number of years of smoking/20).
•Ability to a proper use of pMDI plus spacer and DPI devices.
•A cooperative attitude to be compliant with study procedures.
•Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2

Exclusion Criteria

•Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea or are using one or more of the following acceptable methods of contraception.
•surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
•hormonal contraception (implantable, patch, oral)
•other forms of effective contraception including placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal cream/foam/gel/ suppository.
•Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
•History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
•Patients with abnormal QTcF at Screening Visit: QTcF \> 450 msec for male subjects and QTcF \> 470 msec for female subjects.
•Diagnosis of COPD as defined by the current GOLD guidelines, updates
•Hospitalization due to asthma exacerbation within 1 month prior to the screening visit or during the run-in period.
•Lower respiratory tract infection within one month prior to screening until randomization.

Outcomes

Primary Outcomes

lung bioavailability

Time Frame: 13 times/24hr

To compare the lung bioavailability of B17MP (active metabolite of BDP) and formoterol after four inhalations using the new Chiesi dry powder inhaler vs pMDI using spacer device, with activated Charcoal Block.

Secondary Outcomes

To assess the safety and the tolerability of the study treatments considering AE and measuring vitals signs as blood pressure and heart rate in the specified time frame.(13 times/24hr)