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
2 other identifiers
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Apr 2011
Shorter than P25 for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 9, 2011
CompletedMarch 30, 2017
March 1, 2017
2 months
April 28, 2011
March 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
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®
Plasma Cmax,ss for B17MP
0-12 hours
Secondary Outcomes (5)
evaluation of the pharmacokinetic profile of BDP
0-12 hours
Vital signs assessment
from screening (week -1) to week 8
haematology and blood chemistry assessment
at screening (week - 1) and week 8
Number of patients with Adverse events
during the 11 weeks of study
FEV1 predose assessment
from screening (week-1) to week 8
Study Arms (4)
Clenil® Modulite® via AeroChamber Plus™
EXPERIMENTALClenil® Modulite® administered via AeroChamber Plus™ spacer
Clenil® Modulite® via Volumatic™
ACTIVE COMPARATORClenil® Modulite® administered via Volumatic™ spacer
Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
EXPERIMENTALClenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block
Clenil® Modulite® via Volumatic™ plus charcoal block
ACTIVE COMPARATORClenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Interventions
Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicines Evaluation Unit, Wythenshawe Hospital
Manchester, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Singh, MD
Medicine Evaluation Unit, Manchester, UK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2011
First Posted
June 9, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 30, 2017
Record last verified: 2017-03