NCT01468272

Brief Summary

This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

October 28, 2011

Last Update Submit

July 30, 2020

Conditions

Asthma in Children

Keywords

asthma children NEXT DPI LABA ICS inhalation

Outcome Measures

Primary Outcomes (1)

  • B17MP (active metabolite of BDP) Area Under Curve (AUC)

    B17MP: Profile of Pharmacokinetics

    predose, 15,30min, 1,2,4,6,8 hours post dose

Secondary Outcomes (6)

  • B17MP Cmax,Tmax,T1/2

    predose, 15min,30min,1,2,4,6,8 hours post dose

  • BDP Area Under Curve (AUC), Cmax, Tmax, T1/2

    predose, 15min,30min,1,2,4,6,8 hours postdose

  • Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2

    predose, 15min, 30 min, 1,2,4,6,8 hours postdose

  • plasma potassium Area Under Curve (AUC), Cmin, Tmin

    predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose

  • Heart Rate: Time averaged Heart Rate value: AUC0-t/t

    predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose

  • +1 more secondary outcomes

Study Arms (2)

reference treatment

ACTIVE COMPARATOR

Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI

Drug: free comb. beclomethasone DPI and formoterol DPI

CHF 1535 NEXT DPI

EXPERIMENTAL

CHF 1535 50/6 NEXT DPI

Drug: CHF 1535 50/6 NEXT DPI

Interventions

free comb. beclomethasone DPI and formoterol DPIDRUG

free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).

reference treatment
CHF 1535 50/6 NEXT DPIDRUG

four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)

CHF 1535 NEXT DPI

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male/Female children aged 5 -11y
  • Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).
  • Children with stable asthma
  • Children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms
  • Forced expiratory volume in one second (FEV1) \> 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment.
  • A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures.

You may not qualify if:

  • Past or present diagnoses of cardiovascular, renal or liver disease
  • Known hypersensitivity to the active treatments
  • Exacerbation of asthma symptoms within the previous 4 weeks
  • Inability to perform the required breathing technique and blood sampling
  • Hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1)
  • Lower respiratory tract infection within 1 month prior to screening (visit 1)
  • Disease (other than asthma) which might influence the outcome of the study
  • Obesity, i.e. \> 97% weight percentile by local standards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BørneAstmaKlinikken, Hans Knudsens Plads 1A,

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Chawes BL, Govoni M, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilsson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Piccinno A, Sergio F, Ciurlia G, Poli G, Acerbi D, Singh D, Bisgaard H. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014 Aug;108(8):1108-16. doi: 10.1016/j.rmed.2014.05.007. Epub 2014 Jun 17.

    PMID: 24993817RESULT

Related Links

Study Officials

  • Hans Bisgaard

    BorneAstmaKlinikken, Copenaghen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

DK(1)