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CompletedNCT01370031Updated Mar 30, 2017

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

A Phase 2 interventional study of Clenil® Modulite® via AeroChamber Plus™ and Clenil® Modulite® via Volumatic™ spacer in Asthma, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • PK
  • Adults
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 16 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Clenil® Modulite® via AeroChamber Plus™

    Clenil® Modulite® administered via AeroChamber Plus™ spacer

    Drug: Clenil® Modulite® via AeroChamber Plus™

  • Active comparator
    Clenil® Modulite® via Volumatic™

    Clenil® Modulite® administered via Volumatic™ spacer

    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

    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

    Drug: Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block

Interventions

  • DrugClenil® Modulite® via AeroChamber Plus™

    Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days

  • DrugClenil® Modulite® via Volumatic™ spacer

    Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days

  • DrugClenil® Modulite® via AeroChamber Plus™ plus charcoal block

    Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)

  • DrugClenil® Modulite® administered via Volumatic™ spacer plus charcoal block

    Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)

06

What researchers measure

Primary outcomes

  1. Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®

    Plasma AUC0-12h,ss for B17MP

    Time frame: 0-12 hours

  2. Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®

    Plasma Cmax,ss for B17MP

    Time frame: 0-12 hours

Secondary outcomes

  1. evaluation of the pharmacokinetic profile of BDP

    AUC and Cmax for BDP

    Time frame: 0-12 hours

  2. Vital signs assessment

    Heart rate and Blood pressure assessment

    Time frame: from screening (week -1) to week 8

  3. haematology and blood chemistry assessment

    haematology and blood chemistry assessment

    Time frame: at screening (week - 1) and week 8

  4. Number of patients with Adverse events

    Adverse events

    Time frame: during the 11 weeks of study

  5. FEV1 predose assessment

    FEV1 predose assessment as lung function parameter

    Time frame: from screening (week-1) to week 8

07

Study locations

1 site
  • Medicines Evaluation Unit, Wythenshawe Hospital
    Manchester, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01370031
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
Jun 9, 2011
Start date
Apr 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Mar 30, 2017

Study contacts

Dave Singh, MD
principal investigator · Medicine Evaluation Unit, Manchester, UK

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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