Who is sponsoring NCT00475813?

NCT00475813 is sponsored by Mundipharma Research Limited.

What drugs are being tested in NCT00475813?

Interventions in NCT00475813: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate).

Is NCT00475813 still recruiting?

NCT00475813 is currently completed. Last updated 22 October 2018.

Last reviewed 2018-10-22 · How we verify

NCT00475813

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

Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma

Completed Phase 3 Last updated 22 October 2018

What this trial tests

Phase 3 trial testing FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) in Asthma in 211 participants. Completed in 1 February 2008.

Timeline

1 March 2007

Primary endpoint
1 February 2008

1 February 2008

Quick facts

Lead sponsor	Mundipharma Research Limited
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Enrollment	211
Start date	1 March 2007
Primary completion	1 February 2008
Estimated completion	1 February 2008
Sites	6 locations across Czechia, France, Germany, Hungary, Poland, Romania

Drugs / interventions tested

FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Mundipharma Research Limited — full company profile →

Who can join

Adults 4 to 12, any sex, with 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.

FEV1, recorded at visits to investigator at 2 wks, 6wks & 12 wks.

Sponsor's own description

Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma.
Crossingham I, Turner S, Ramakrishnan S, Fries A, et al · · 2021 · cited 41× · PMID 33945639 · DOI 10.1002/14651858.cd013518.pub2
A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma.
Emeryk A, Klink R, McIver T, Dalvi P. · · 2016 · cited 10× · PMID 27185164 · DOI 10.1177/1753465816646320
Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events.
O'Shea O, Stovold E, Cates CJ. · · 2021 · cited 6× · PMID 33852162 · DOI 10.1002/14651858.cd007694.pub3

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

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 NCT00475813 (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/NCT00475813.

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