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NCT01266980
A Study to Assess the Effects of Repeat Doses of Fluticasone Furoate and GW642444M Combination in Healthy Subjects and in Subjects With Severe Impairment.
Phase 1 trial testing Inhaled FF/ GW642444M (200/25mcg) in Pulmonary Disease, Chronic Obstructive in 18 participants. Completed in 22 March 2011.
22 March 2011
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 18 November 2010 |
| Primary completion | 22 March 2011 |
| Estimated completion | 22 March 2011 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Inhaled FF/ GW642444M (200/25mcg) — full drug profile →
Conditions studied
- Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 70, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will assess the saftey of giving fluticasone furoate 200mcg/GW642444M 25mcg once daily for 7 days to patients with severe renal imparement. The results of this study will aid in deciding whether a FF/GW642444M doseadjustment is justified in subjects with severe renal impairment and in estimating any such adjustments.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Influence of renal and hepatic impairment on the pharmacokinetic and pharmacodynamic properties and tolerability of fluticasone furoate and vilanterol in combination.
Allen A, Davis A, Hardes K, Tombs L, et al · · 2012 · cited 14× · PMID 23200625 · DOI 10.1016/j.clinthera.2012.11.001 -
Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy.
Albertson TE, Bullick SW, Schivo M, Sutter ME. · · 2016 · cited 7× · PMID 28008228 · DOI 10.2147/dddt.s113573
Verify or expand the search:
- PubMed search for NCT01266980
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT01266980 (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 GlaxoSmithKline
- Last refreshed: 3 August 2017
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/NCT01266980.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing