A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)
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ClinicalTrials.gov Identifier: NCT01245426 |
Recruitment Status
:
Completed
First Posted
: November 22, 2010
Last Update Posted
: December 1, 2016
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | |||||
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First Submitted Date ICMJE | November 19, 2010 | ||||
First Posted Date ICMJE | November 22, 2010 | ||||
Last Update Posted Date | December 1, 2016 | ||||
Study Start Date ICMJE | December 2010 | ||||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1 [ Time Frame: Day 28 ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01245426 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1) | ||||
Official Title ICMJE | A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study to Determine the Efficacy and Dose Response of Repeat Inhaled Doses of GW870086X on FEV1 in Adults With Persistent Asthma | ||||
Brief Summary | This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily. | ||||
Detailed Description | This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled doses of GW870086X on FEV1. GW870086X is a novel inhaled corticosteroid with potent glucocorticoid activity currently in development by GlaxoSmithKline (GSK) as an inhaled treatment of persistent asthma. Initially, subjects will be randomised to receive placebo, 2mg or 4mg GW870086X once daily. An interim analysis will be performed on the primary endpoint to potentially adapt the study design after approximately 45 subjects have completed dosing. Based on the results of the interim analysis, the trial may continue to completion using the original doses or an adaptation to the doses could be made. Either the 1mg GW870086X once daily arm or 3mg GW870086X once daily arm may be added, or the trial could be terminated early. After screening there will be a 4 week run in period prior to start of treatment and after will be a follow up period 1-2 weeks after last dose. Approximately 120 subjects will complete the study. Key safety assessments include; clinical laboratory tests, vital signs and collection of adverse events (AE's). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Asthma | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
136 | ||||
Original Estimated Enrollment ICMJE |
150 | ||||
Actual Study Completion Date | August 2011 | ||||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Bulgaria, Germany, South Africa | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01245426 | ||||
Other Study ID Numbers ICMJE | 114749 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||
Verification Date | November 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |