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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01370031
First received: April 28, 2011
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Clenil® Modulite® via AeroChamber Plus™
Drug: Clenil® Modulite® via Volumatic™ spacer
Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® [ Time Frame: 0-12 hours ] [ Designated as safety issue: Yes ]
    Plasma AUC0-12h,ss for B17MP

  • Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® [ Time Frame: 0-12 hours ] [ Designated as safety issue: Yes ]
    Plasma Cmax,ss for B17MP


Secondary Outcome Measures:
  • evaluation of the pharmacokinetic profile of BDP [ Time Frame: 0-12 hours ] [ Designated as safety issue: Yes ]
    AUC and Cmax for BDP

  • Vital signs assessment [ Time Frame: from screening (week -1) to week 8 ] [ Designated as safety issue: Yes ]
    Heart rate and Blood pressure assessment

  • haematology and blood chemistry assessment [ Time Frame: at screening (week - 1) and week 8 ] [ Designated as safety issue: Yes ]
    haematology and blood chemistry assessment

  • Number of patients with Adverse events [ Time Frame: during the 11 weeks of study ] [ Designated as safety issue: Yes ]
    Adverse events

  • FEV1 predose assessment [ Time Frame: from screening (week-1) to week 8 ] [ Designated as safety issue: Yes ]
    FEV1 predose assessment as lung function parameter


Enrollment: 16
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370031

Locations
United Kingdom
Medicines Evaluation Unit, Wythenshawe Hospital
Manchester, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Dave Singh, MD Medicine Evaluation Unit, Manchester, UK
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01370031     History of Changes
Other Study ID Numbers: CCD-1008-PR-0049, 2010-022615-19
Study First Received: April 28, 2011
Last Updated: December 21, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma
PK
Adults

Additional relevant MeSH terms:
Charcoal
Antidotes
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 30, 2014