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

NCT01245426 | Completed Phase 2

• 1 other identifier: 114749
• Study Type: interventional
• Target: 136
• Locations: 3 countries
• Sites: 11

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.

Conditions

Asthma

Keywords

Asthma; GW870086; Efficacy; FEV1

Outcome Measures

Primary Outcomes (1)

• Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1

  Day 28

Secondary Outcomes (4)

• Change from baseline in FEV1 on Day 7, Day 14 and Day 21

  Days; 7, 14, 21

• Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days

  Days 1-28

• Rescue medication usage

  Days 1-28

• Assessment of vital signs, safety laboratory parameters and incidences of adverse events throughout treatment period

  9-10 weeks

Study Arms (5)

GW870086 2mg

EXPERIMENTAL

GW870086 2mg once daily in the morning for 27 ± 2 days

Drug: GW870086 2mg

GW870086 4mg

EXPERIMENTAL

GW870086 4mg once daily in the morning for 27 ± 2 days

Drug: GW870086 4mg

Placebo

PLACEBO COMPARATOR

Placebo once daily in the morning for 27 ± 2 days

Drug: GW870086 Placebo

GW870086 1mg

EXPERIMENTAL

GW870086 1mg once daily in the morning for 27 ± 2 days

Drug: GW870086 1mg

GW870086 3mg

EXPERIMENTAL

GW870086 3mg once daily in the morning for 27 ± 2 days

Drug: GW870086 3mg

Interventions

GW870086 2mg DRUG

oral inhalation

GW870086 2mg

GW870086 4mg DRUG

oral inhalation

GW870086 4mg

GW870086 Placebo DRUG

oral inhalation

Placebo

GW870086 1mg DRUG

oral inhalation

GW870086 1mg

GW870086 3mg DRUG

oral inhalation

GW870086 3mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Sofia, 1612, Bulgaria

Location

GSK Investigational Site

Hamburg, Hamburg, 20354, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10969, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

Location

GSK Investigational Site

Bloemfontein, 9301, South Africa

Location

GSK Investigational Site

George, 6529, South Africa

Location

GSK Investigational Site

Newton Park, Port Elizabeth, 6045, South Africa

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

GW870086X

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (7); BU (1); ZA (3)