Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects

NCT00483899 | Completed Phase 1

• 1 other identifier: SIG102335
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)

Conditions

Asthma

Keywords

GW870086X Asthma Crossover repeat dose inhaled

Outcome Measures

Primary Outcomes (1)

• Change in lung function 2 hours after treatment on day 7

  on day 7

Secondary Outcomes (1)

• Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs

  2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;

Study Arms (3)

Cohort 1: Part A

EXPERIMENTAL

Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.

Drug: GW870086X; Drug: Placebo

Cohort 2: Part A

EXPERIMENTAL

Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.

Drug: GW870086X; Drug: Placebo

Part B

EXPERIMENTAL

Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.

Drug: GW870086X; Drug: Placebo

Interventions

GW870086X DRUG

Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times

Cohort 1: Part A; Cohort 2: Part A; Part B

Placebo DRUG

Placebo matching GW870086X will be administered by subjects

Cohort 1: Part A; Cohort 2: Part A; Part B

Eligibility Criteria

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

You may qualify if:

• Male subjects aged 18-55
• Documented history of bronchial asthma diagnosed at least 6 months ago.
• Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin
• Documented sensitivity to adenosine mono phosphate (AMP) at screening visit
• Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit

You may not qualify if:

• Any significant illness or disease
• History of life threatening asthma
• History of respiratory tract infection
• Subjects who take medication for their asthma, or other conditions, not compatible with this study.
• Smoker
• Subjects who are oversensitive to corticosteroids
• History of drug or alcohol abuse
• Donated blood within last 3 months
• Been involved in another clinical trial during the last 3 months
• Subjects who work night shifts
• Subjects who are undergoing de-sensitisation therapy

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Manchester, Lancashire, M23 9LT, United Kingdom

Location

GSK Investigational Site

London, SE5 8AF, United Kingdom

Location

GSK Investigational Site

London, United Kingdom

Location

Related Links

• Results for study SIG102335 can be found on the GSK Clinical Study Register.

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 7, 2007
• Study Start: October 7, 2005
• Primary Completion: December 15, 2006
• Study Completion: December 15, 2006
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

GB (3)