CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
400 microgrammes GSK961081 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00674817
NCT00674817Phase 2Completed

A Randomized, Double-blind, Crossover Study to Investigate the Bronchodilatation Post-inhalation of GSK961081 Alone and With the Addition of Cumulative Doses of Short Acting Bronchodilators (Salbutamol and Ipratropium Bromide) in Patients With COPD

Theravance Biopharma·interventional·Posted May 8, 2008·Updated Oct 20, 2021

In Brief

A Phase 2 clinical trial evaluating 400 microgrammes GSK961081 and 1200 microgrammes GSK961081 for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 45 participants across 4 sites in 3 countries.

Detailed Summary

GSK961081 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNew Zealand, Thailand, United Kingdom
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2008
Study CompletionOct 19, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.2 years ago

Interventions

400 microgrammes GSK961081drug

Inhaled GSK961081 administered via Dry Powder Inhaler.

1200 microgrammes GSK961081drug

Inhaled GSK961081 adminisntered via dry powder inhaler.