Last reviewed · How we verify
NCT00995800: FLT2503
A Double-blind, Randomised, Incomplete Block, Crossover, Placebo-controlled, Dose-response Study to Assess Bronchial Hyperresponsiveness and Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adult Subjects With Mild to Moderate Asthma
Phase 2 trial testing Fluticasone propionate / Formoterol fumarate in Asthma in 46 participants. Completed in 1 July 2010.
1 July 2010
Quick facts
| Lead sponsor | Mundipharma Research Limited |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 October 2009 |
| Primary completion | 1 July 2010 |
| Estimated completion | 1 July 2010 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Fluticasone propionate / Formoterol fumarate
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Mundipharma Research Limited — full company profile →
Who can join
Adults 18 to 55, 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.
- Effects of each dose strength on bronchial hyperresponsiveness to inhaled adenosine 5'-monophosphate (AMP) challenge.
Sponsor's own description
This is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00995800
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Asthma
Currently open trials in the same condition.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT00995800 (US National Library of Medicine, public domain)
- 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/NCT00995800.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing