Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices

March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.

Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device Versus the Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adults Patients

The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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
        • Medicines Evaluation Unit, Wythenshawe Hospital

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non-pregnant female patients aged 18-65 years included.
  • Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening.
  • Patients already treated with a dose of BDP or equivalent up to 2000 µg/day.
  • FEV1 ≥ 60% of predicted for the patient's normal value at screening and randomisation

Exclusion Criteria:

  • Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
  • Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation.
  • Lower respiratory tract infection within one month prior to screening.
  • Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines.
  • Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion.
  • Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening.
  • Any enzyme inducing or inhibiting drug (from 8 weeks before screening visit)
  • Patients who received any investigational new drug within the last 8 weeks before the screening. The patients cannot participate in another clinical study at the same time as the present study.
  • Blood donation (450 mL or more)or significant blood loss less than 12 weeks before the first intake of study drug.

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: Clenil® Modulite® via AeroChamber Plus™
Clenil® Modulite® administered via AeroChamber Plus™ spacer
Drug: Clenil® Modulite® via AeroChamber Plus™
Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
Active Comparator: Clenil® Modulite® via Volumatic™
Clenil® Modulite® administered via Volumatic™ spacer
Drug: Clenil® Modulite® via Volumatic™ spacer
Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
Experimental: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block
Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
Active Comparator: Clenil® Modulite® via Volumatic™ plus charcoal block
Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Time Frame: 0-12 hours
Plasma AUC0-12h,ss for B17MP
0-12 hours
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Time Frame: 0-12 hours
Plasma Cmax,ss for B17MP
0-12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the pharmacokinetic profile of BDP
Time Frame: 0-12 hours
AUC and Cmax for BDP
0-12 hours
Vital signs assessment
Time Frame: from screening (week -1) to week 8
Heart rate and Blood pressure assessment
from screening (week -1) to week 8
haematology and blood chemistry assessment
Time Frame: at screening (week - 1) and week 8
haematology and blood chemistry assessment
at screening (week - 1) and week 8
Number of patients with Adverse events
Time Frame: during the 11 weeks of study
Adverse events
during the 11 weeks of study
FEV1 predose assessment
Time Frame: from screening (week-1) to week 8
FEV1 predose assessment as lung function parameter
from screening (week-1) to week 8

Collaborators and Investigators

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

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Dave Singh, MD, Medicine Evaluation Unit, Manchester, UK

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

April 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-1008-PR-0049
  • 2010-022615-19 (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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