Study to Evaluate GSK2190915 in Subjects With Mild Asthma

NCT00812773 | Completed Phase 2

• 1 other identifier: 112356
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung function in mild asthmatics using a number of clinical and biological markers of efficacy.

Conditions

Asthma

Keywords

GSK2190915; Repeat; Oral; Dose; Challenge; Asthma; Allergen

Outcome Measures

Primary Outcomes (1)

• Early Asthmatic Response

  0-2 hours after allergen challenge on Day 3 of each treatment period.

Secondary Outcomes (2)

• Lung function as measured by FEV1

  Days 1 and 3

• Assess safety and tolerability

  Throughout study

Study Arms (1)

3 day repeat dose

EXPERIMENTAL

Drug: GSK2190915

Interventions

GSK2190915 DRUG

Investigational Product

3 day repeat dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2)
• Female subjects must be of non childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL and estradiol \< 40 pg/ml (\<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
• Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 5 terminal half-lives post-last dose.
• 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 -agonist therapy by inhalation.
• Pre-bronchodilator FEV1 \>70% of predicted at screening.
• Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \<= 10 pack years.
• \[number of pack years = (number of cigarettes per day/20) x number of years smoked\]
• Demonstration of a positive wheal and flare reaction (\>= 3 mm relative to negative control) to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair) on skin prick testing at screening, or within 12 months of study start.
• Methacholine challenge PC20 \< 8 mg/mL at screening or previous (in last 6 months) AMP, histamine or methacholine challenge that confirms the diagnosis of asthma
• Screening allergen challenge demonstrates that the subject experiences an early asthmatic response. The early asthmatic response must include a fall in FEV1 of \>= 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. Data obtained from screening for LPA111834 may be used for this criteria.
• Signed and dated written informed consent is obtained from the subject
• The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.

You may not qualify if:

• Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease
• 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 \>150 mmHg 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
• Symptomatic with hay fever at screening or predicted to have symptomatic hay fever during the time of study
• Administration of oral or injectable steroids within 5 weeks of screening or intranasal and/or inhaled steroids within 4 weeks of the screening visit.
• Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments eg headache from 14 days before screening until the follow-up visit.
• Unable to abstain from short acting beta agonists within 8 hours prior to an allergen challenge, dosing with study drug or any lung function assessment.
• If, after 2 concurrent administrations of saline during the allergen challenge at screening the subjects still have a fall in FEV1 of greater than 10%.
• The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months prior to the first dosing day.
• History of being unable to tolerate or complete allergen challenge tests.
• Subject is undergoing allergen desensitisation therapy.
• There is a risk of non-compliance with study procedures.
• History of blood donation (500 mL) within 3 months of starting the clinical study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

GSK Investigational Site

London, W1G 8HU, United Kingdom

Location

GSK Investigational Site

Manchester, M23 9QZ, United Kingdom

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

3-(3-tert-butylsulfanyl-1-(4-(6-ethoxypyridin-3-yl)benzyl)-5-(5-methylpyridin-2-ylmethoxy)-1H-indol-2-yl)-2,2-dimethylpropionic acid

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: December 8, 2008
• First Posted: December 22, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (3)