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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Clenil® Modulite® via AeroChamber Plus™; Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block; Drug: Clenil® Modulite® via Volumatic™ spacer; Drug: Clenil® Modulite® via AeroChamber Plus™ plus charcoal block

• Registration Number: NCT01370031
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-28
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clenil® Modulite® via AeroChamber Plus™	Clenil® Modulite® via AeroChamber Plus™	Clenil® Modulite® administered via AeroChamber Plus™ spacer
Clenil® Modulite® via Volumatic™ plus charcoal block	Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block	Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Clenil® Modulite® via Volumatic™	Clenil® Modulite® via Volumatic™ spacer	Clenil® Modulite® administered via Volumatic™ spacer
Clenil® Modulite® via AeroChamber Plus™ plus charcoal block	Clenil® Modulite® via AeroChamber Plus™ plus charcoal block	Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block

Primary Outcome Measures

Name	Time	Method
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®	0-12 hours	Plasma Cmax,ss for B17MP

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medicines Evaluation Unit, Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom