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400 microgrammes GSK961081

An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.

Ensayo de Theravance Biopharma, Inc. en Pulmonary Disease, Chronic Obstructive (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

45

previstos

Centros

4

Fin del objetivo primario

oct 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en abr 2008.

Qué mide

Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h. (Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroGSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration. If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in the presence of the short acting beta agonist salbutamol and the short acting muscarinic antagonist, ipratropium bromide will be measured in this study. Any residual bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic components of GSK961081

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Ficha completa en ClinicalTrials.gov (NCT00674817), actualizada en sep 2021.