Clinical trial NCT01370031: Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
PK
Adults
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
timeFrame: 0-12 hours
measure: Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
timeFrame: 0-12 hours
Secondary outcomes:
measure: evaluation of the pharmacokinetic profile of BDP
timeFrame: 0-12 hours
measure: Vital signs assessment
timeFrame: from screening (week -1) to week 8
measure: haematology and blood chemistry assessment
timeFrame: at screening (week - 1) and week 8
measure: Number of patients with Adverse events
timeFrame: during the 11 weeks of study
measure: FEV1 predose assessment
timeFrame: from screening (week-1) to week 8
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit, Wythenshawe Hospital
Study officials:
affiliation: Medicine Evaluation Unit, Manchester, UK
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: