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

April 28, 2011
December 21, 2011
April 2011
June 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01370031 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Clenil® Modulite® via AeroChamber Plus™
    Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
  • Drug: Clenil® Modulite® via Volumatic™ spacer
    Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
  • Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
    Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
  • 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)
  • Experimental: Clenil® Modulite® via AeroChamber Plus™
    Clenil® Modulite® administered via AeroChamber Plus™ spacer
    Intervention: Drug: Clenil® Modulite® via AeroChamber Plus™
  • Active Comparator: Clenil® Modulite® via Volumatic™
    Clenil® Modulite® administered via Volumatic™ spacer
    Intervention: Drug: Clenil® Modulite® via Volumatic™ spacer
  • Experimental: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
    Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block
    Intervention: Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
  • Active Comparator: Clenil® Modulite® via Volumatic™ plus charcoal block
    Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
    Intervention: Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01370031
CCD-1008-PR-0049, 2010-022615-19
No
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Dave Singh, MD Medicine Evaluation Unit, Manchester, UK
Chiesi Farmaceutici S.p.A.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP