CClinicalTrials.gg
Sign In
CompletedNCT01191424ADONEUpdated Jul 31, 2020

A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.

A Phase 2 interventional study of CHF1535 NEXT DPI and BDP DPI and formoterol DPI in Asthma, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-31.

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

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.

02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • Asthma
  • PK
  • Adolescents
  • Adults
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 57 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
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  1. Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
  2. Written informed consent;
  3. Diagnosis of asthma as defined in the GINA guidelines;
  4. Patients with stable asthma, according to the Investigator's opinion;
  5. Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
  6. Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values;
  7. Patients with a peak inspiratory flow (PIF) > 40 L/min
  8. Reversibility test;
  9. Non- or ex-smokers;
  10. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;

Main Exclusion Criteria:

  1. Pregnant or lactating female;
  2. Having received an investigational drug within 2 months before the screening visit
  3. Diagnosis of COPD as defined by the current GOLD guidelines;
  4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
  5. Known hypersensitivity to the active treatments;
  6. History of drug addiction or excessive use of alcohol;
  7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
  8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
  9. Inability to perform the required breathing technique and blood sampling;
  10. Lower respiratory tract infection within 1 month prior to the screening visit;
  11. Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.
05

Study design

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

Study arms

  • Experimental
    CHF1535 NEXT DPI

    Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI

    Drug: CHF1535 NEXT DPI

  • Active comparator
    Free combination BDP and FF

    Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF

    Drug: BDP DPI and formoterol DPI

Interventions

  • DrugCHF1535 NEXT DPI

    FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER

  • DrugBDP DPI and formoterol DPI

    FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI

06

What researchers measure

Primary outcomes

  1. Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI

    Plasma AUC0-t for B17MP

    Time frame: 0-8hrs

Secondary outcomes

  1. Different pharmacokinetic parameters

    BDP/B17MP and FF PK parameters

    Time frame: 0-8hrs

  2. Lung function parameters

    Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).

    Time frame: 0-8hrs

  3. Plasma potassium

    Plasma Potassium Cmin, tmin and AUC0-t

    Time frame: 0-8hrs

  4. Plasma glucose

    Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t

    Time frame: 0-8hrs

  5. Heart rate

    time averaged value (AUC0-t/8)

    Time frame: 0-8hrs

  6. Adverse Events

    Time frame: during the whole study period

07

Study locations

2 sites
  • Copenhagen University Hospital
    Copenhagen, 2800, Denmark
  • Medicines Evaluation Unit
    Manchester, M23 9QZ, United Kingdom
08

References and documents

Publications

  • Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16. PubMed 24746942 ↗
  • Chawes BL, Govoni M, Piccinno A, Kreiner-Moller E, Vissing NH, Mortensen L, Nilsson E, Bisgaard A, Deleuran M, Skytt N, Samandari N, Acerbi D, Bisgaard H. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014 Nov;78(5):1169-71. doi: 10.1111/bcp.12424. No abstract available. PubMed 24830339 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01191424
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
Aug 30, 2010
Start date
Oct 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 31, 2020

Study contacts

Dave Singh, MD
study director · Medicines Evaluation Unit
Hans Bisgaard, MD
study director · Copenhagen University Hospital at Herlev

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Other studies from this sponsor

Chiesi Farmaceutici S.p.A.

Start the discussion