Who is sponsoring NCT02063139?

NCT02063139 is sponsored by Mundipharma Research Limited.

What drugs are being tested in NCT02063139?

Interventions in NCT02063139: Flutiform 50/5 ug (2 puffs bid) pMDI, Fluticasone 50 ug (2puffs bid) pMDI, Beclometasone Autohaler 50 ug (2 puffs bid).

What condition does NCT02063139 study?

NCT02063139 studies Mild Persistent Asthma.

Is NCT02063139 still recruiting?

NCT02063139 is currently completed. Last updated 22 October 2018.

Last reviewed 2018-10-22 · How we verify

NCT02063139

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemometry

Completed Phase 2 Last updated 22 October 2018

What this trial tests

Phase 2 trial testing Flutiform 50/5 ug (2 puffs bid) pMDI in Mild Persistent Asthma in 48 participants. Completed in 1 January 2015.

Timeline

1 February 2014

Primary endpoint
1 June 2014

1 January 2015

Quick facts

Lead sponsor	Mundipharma Research Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	1 February 2014
Primary completion	1 June 2014
Estimated completion	1 January 2015
Sites	1 location across Denmark

Drugs / interventions tested

Flutiform 50/5 ug (2 puffs bid) pMDI — full drug profile →
Fluticasone 50 ug (2puffs bid) pMDI — full drug profile →
Beclometasone Autohaler 50 ug (2 puffs bid) — full drug profile →

Conditions studied

Mild Persistent Asthma — all drugs for Mild Persistent Asthma →

Sponsor

Mundipharma Research Limited — full company profile →

Who can join

Adults 5 to 12, any sex, with Mild Persistent Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
Time frame: Change from baseline in growth rate during the each treatment and washout period which is 2 weeks
Lower leg length will be measured in the afternoon, between 13:00 and 19:00h. Each individual subject will have their knemometry measurements performed at the same time of day (+/- 1 hour).

Sponsor's own description

Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Pilot Study of the Normative Range of Overnight Urinary Free Cortisol Corrected for Creatinine in Children.
Wolthers OD, Mersmann S, Dissanayake S. · · 2018 · PMID 29256049 · DOI 10.1007/s40261-017-0609-x

Verify or expand the search:

Other Mundipharma Research Limited trials

Trials by the same sponsor.

NCT06794554 — Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options · Phase 2 · recruiting
NCT05534529 — Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age · Phase 1 · terminated
NCT05432375 — Study of Tinostamustine for Adjuvant Treatment of Glioblastoma · EARLY_PHASE1 · completed
NCT04368559 — Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Unde · Phase 3 · completed
NCT03345485 — Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02063139 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mundipharma Research Limited
Last refreshed: 22 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02063139.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing