A Study to Evaluate the Effect of Repeat Doses of GW870086X in Mild to Moderate Asthmatics

NCT00945932 | Completed Phase 2

• 1 other identifier: 112851
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 8

Brief Summary

This study will measure the effect of repeat inhaled doses of GW870086X on lung function.

Conditions

Asthma

Keywords

asthma; GW870086X; Efficacy; FEV1; repeat-dose

Outcome Measures

Primary Outcomes (1)

• Lung function as measured by FEV1

  Day 28

Secondary Outcomes (4)

• Lung function as measured by FEV1

  Day 7 and 14

• Lung function as measured by PEFR

  Twice daily over 28 days

• Rescue medication usage

  4-5 months

• Assess safety and tolerability

  4-5 months

Study Arms (1)

28 day repeat dose

EXPERIMENTAL

Drug: GW870086X; Drug: Placebo

Interventions

GW870086X DRUG

Investigational product

28 day repeat dose

Placebo DRUG

Placebo control

28 day repeat dose

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 of age inclusive, at the time of signing the informed consent.
• A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and oestradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\]. 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. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
• Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose.
• Body weight, men \>/= 50 kg, women \>/= 45 kg and BMI within the range 19.0 - 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 by inhalation.
• Severity of Disease: A best FEV1 of 40%-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, which includes compliance with the requirements and restrictions listed in the consent form.
• 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 pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• A positive pre-study drug/alcohol screen.
• Subject is mentally or legally incapacitated.
• Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
• Clinically significant abnormalities in safety laboratory analysis at screening.
• Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP \>140mmHg or diastolic BP \> 90mmHg.
• Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
• 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.
• Administration of intranasal and/or inhaled steroids within 2 week of the screening visit. Prior to this the subject's maximum daily dose must be less than FP equivalent 250mcg.
• Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear 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.
• Asthma Exacerbation: 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
• The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• A positive test for HIV antibody.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14057, Germany

Location

Related Publications (1)

• Bareille P, Hardes K, Donald AC. Efficacy and safety of once-daily GW870086 a novel selective glucocorticoid in mild-moderate asthmatics: a randomised, two-way crossover, controlled clinical trial. J Asthma. 2013 Dec;50(10):1077-82. doi: 10.3109/02770903.2013.837480. Epub 2013 Oct 1.

  PMID: 23991670 DERIVED

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (8)