CompletedNCT01450774Updated Mar 29, 2017

Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

A Phase 3 interventional study of CHF 1535 50/6µg and beclomethasone dipropionate 50µg + formoterol fumarate 6µg in Childhood Asthma, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 1 site in Denmark. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 5 Years to 11 Years
Sex: All

Study summary

This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.

Conditions studied

Childhood Asthma

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Asthma 3,921

In context

Asthma

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

This study's enrollment of 72 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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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.

Who can participate

Ages eligible: 5 Years to 11 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment
Clinical diagnosis of mild asthma during at least two months prior to screening visit
Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit

Exclusion criteria

Exclusion Criteria:

Endocrinological diseases including growth impairment or other chronic diseases
Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 72 participants (actual)

Study arms

Experimental
CHF 1535 50/6µg
Drug: CHF 1535 50/6µg
Active comparator
beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Drug: beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Interventions

DrugCHF 1535 50/6µg
fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Drugbeclomethasone dipropionate 50µg + formoterol fumarate 6µg
free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

What researchers measure

Primary outcomes

Lower leg growth rate measured by knemometry
Time frame: after a 2 week treatment

Secondary outcomes

24-hour urinary free cortisol/creatinine levels
Time frame: after a 2 week treatment period
Changes in pre-dose morning and evening PEF (L/min)
Time frame: pre and after a 2 week treatment period

Study locations

1 site

BørneAstmaKlinikken
Copenhagen, 2100, Denmark

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01450774
Lead sponsor: Chiesi Farmaceutici S.p.A.
Responsible party: Sponsor
First posted: Oct 12, 2011
Start date: Sep 2011
Primary completion: Nov 2013
Completion: Feb 2014
Last update: Mar 29, 2017

Study contacts

Hans Bisgaard, MD

principal investigator · BørneAstmaKlinikken

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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