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

October 28, 2021 updated by: Chiesi Farmaceutici S.p.A.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • The Medicine Evaluation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEXThaler 100/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg
Drug: NEXThaler 100/6 mcg DPI
Other Names:
  • Fixed combination of BDP plus formoterol fumarate
Experimental: NEXThaler 200/6 mcg DPI
Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg
Drug: NEXThaler 200/6 mcg DPI
Other Names:
  • Fixed combination of BDP plus formoterol fumarate
Placebo Comparator: NEXThaler placebo
Single dose (4 inhalations)
Drug: NEXThaler placebo
Placebo comparator
Experimental: NEXThaler 100/6 mcg plus CB
Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg
Drug: NEXThaler 100/6 mcg DPI
Other Names:
  • Fixed combination of BDP plus formoterol fumarate
Experimental: NEXThaler 200/6 mcg plus CB
Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg
Drug: NEXThaler 200/6 mcg DPI
Other Names:
  • Fixed combination of BDP plus formoterol fumarate
Active Comparator: Flixotide Accuhaler 500 mcg
Single dose (2 inhalations) of fluticasone propionate
Drug: Flixotide Accuhaler 500 mcg
Active comparator
Other Names:
  • Fluticasone Propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Formoterol AUC0-t and B17MP AUC0-t
Time Frame: from predose until 12 hr post dose
from predose until 12 hr post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BDP pharmacokinetic (PK) parameters
Time Frame: from predose until 12 hr post dose
The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2
from predose until 12 hr post dose
Other PK parameter of B17MP and formoterol
Time Frame: from predose until 12 hours postdose
the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2
from predose until 12 hours postdose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma glucose
Time Frame: from predose until 12 hours postdose
the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmax and tmax
from predose until 12 hours postdose
Heart rate (HR)
Time Frame: from predose until 12 hours postdose
the following parameters will be evaluated: HR AUC0-12/12h
from predose until 12 hours postdose
Plasma cortisol
Time Frame: from predose until 24 hours postdose
the following parameters will be evaluated: AUC0-24, Cmin and tmin
from predose until 24 hours postdose
Plasma potassium
Time Frame: from predose until 12 hours postdose
the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmin ad tmin
from predose until 12 hours postdose
Systolic and Diastolic Blood Pressure (SBP and DBP)
Time Frame: from predose until 12 hours postdose
the following parameters will be evaluated: SBP AUC0-12/12h and DBP AUC0-12/12h
from predose until 12 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-1205-PR-0087
  • 2012-002370-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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