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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370031
• Other study ID #: CCD-1008-PR-0049
• Secondary ID: 2010-022615-19
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2011
• Last updated: March 28, 2017
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Clenil® Modulite® via AeroChamber Plus™
Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
• Clenil® Modulite® via Volumatic™ spacer
Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
• Clenil® Modulite® via AeroChamber Plus™ plus charcoal block
Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
• Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)

Locations

Country	Name	City	State
United Kingdom	Medicines Evaluation Unit, Wythenshawe Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

•   Study Record on EU Clinical Trials Register including results