A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)

Tracking Information
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; (submitted: November 19, 2010)	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; (submitted: December 2, 2010)	Change from baseline in FEV1 on Day 7, Day 14 and Day 21 [ Time Frame: Days; 7, 14, 21 ]; Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days [ Time Frame: Days 1-28 ]; Rescue medication usage [ Time Frame: Days 1-28 ]; Assessment of vital signs, safety laboratory parameters and incidences of adverse events throughout treatment period [ Time Frame: 9-10 weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: November 19, 2010)	Change from baseline in FEV1 on Day 7, Day 14 and Day 21 [ Time Frame: Days; 7, 14, 21 ]; Change from baseline in PEFR measured twice daily over 28 days [ Time Frame: Days 1-28 ]; Rescue medication usage [ Time Frame: Days 1-28 ]; Assessment of vital signs, safety laboratory parameters and incidences of adverse events throughout treatment period [ Time Frame: 9-10 weeks ]
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
Condition ICMJE	Asthma
Intervention ICMJE	Drug: GW870086 2mg oral inhalation; Drug: GW870086 4mg oral inhalation; Drug: GW870086 Placebo oral inhalation; Drug: GW870086 1mg oral inhalation; Drug: GW870086 3mg oral inhalation
Study Arms	Experimental: GW870086 2mg GW870086 2mg once daily in the morning for 27 ± 2 days Intervention: Drug: GW870086 2mg; Experimental: GW870086 4mg GW870086 4mg once daily in the morning for 27 ± 2 days Intervention: Drug: GW870086 4mg; Placebo Comparator: Placebo Placebo once daily in the morning for 27 ± 2 days Intervention: Drug: GW870086 Placebo; Experimental: GW870086 1mg GW870086 1mg once daily in the morning for 27 ± 2 days Intervention: Drug: GW870086 1mg; Experimental: GW870086 3mg GW870086 3mg once daily in the morning for 27 ± 2 days Intervention: Drug: GW870086 3mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 4, 2011)	136
Original Estimated Enrollment ICMJE; (submitted: November 19, 2010)	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: Male or female between 18 and 65 years; A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.; Male subjects must agree to use one of the protocol contraception methods.; Body weight, men ≥ 50 kg, women ≥ 45 kg and BMI within the range 18.5 - 29.0 kg/m2 (inclusive).; Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-2 agonist therapy; Severity of Disease: A best FEV1 of 60%-85% of the predicted normal value during the Visit 1 screening period.; No history of smoking within 6 months of the start of the study and with a total pack year history of ≤10 pack years; Capable of giving written informed consent; Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.; AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Exclusion Criteria: A positive test for Hepatitis B or Hepatitis C antibody.; Current or chronic history of liver disease, or known hepatic or biliary abnormalities; The subject has a positive pre-study drug/alcohol screen unless a positive can be explained by the patients' medication.; Past or present disease, which as judged by the investigator, may affect the outcome of this study.; Clinically significant abnormalities in safety laboratory analysis at screening, as determined by the investigator.; Subject is hypertensive at screening.; History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.; Administration of oral, injectable or dermal steroids within 8 weeks of screening.; Exacerbation of asthma within 4 weeks prior to the first dose of study medication.; Respiratory Infection that is not resolved within the 4 weeks before screening and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.; Any asthma exacerbation requiring oral corticosteroids within 8 weeks of screening. A subject must not have had any hospitalisation for asthma within 6 months prior to screening; A positive test for HIV antibody.; History of regular alcohol consumption within 6 months of the study.; The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).; Exposure to more than four new chemical entities within 12 months prior to the first dosing day.; Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up.; Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-2 agonists within 1 week prior to screening and is unable to abstain from them throughout the study.; Unable to abstain from other medications other than short acting inhaled beta-2 agonists and paracetamol (up to 4 g per day) 7 days before screening until the follow-up visit.; Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, from screening and throughout the study.; Unable to use the DISKHALER® device correctly.; History of sensitivity to any of the study medications.; Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period.; Unwillingness or inability to follow the procedures outlined in the protocol.; The subject is not able to understand or comply with protocol requirements, instructions and protocol stated restrictions.; Vulnerable subjects.; Subject is mentally or legally incapacitated.; Urinary cotinine levels indicative of smoking or history within 6 months prior to screening.; Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Sex/Gender	Sexes Eligible for Study: All
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	Plan to Share IPD: Yes Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party	GlaxoSmithKline
Study Sponsor ICMJE	GlaxoSmithKline
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: GSK Clinical Trials GlaxoSmithKline
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