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

September 27, 2017 updated by: GlaxoSmithKline

Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • GSK Investigational Site
      • London, United Kingdom, SE5 8AF
        • GSK Investigational Site
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M23 9LT
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Part A
Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
Drug: GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Drug: Placebo
Placebo matching GW870086X will be administered by subjects
Experimental: Cohort 2: Part A
Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
Drug: GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Drug: Placebo
Placebo matching GW870086X will be administered by subjects
Experimental: Part B
Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
Drug: GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Drug: Placebo
Placebo matching GW870086X will be administered by subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lung function 2 hours after treatment on day 7
Time Frame: on day 7
on day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;
2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2005

Primary Completion (Actual)

December 15, 2006

Study Completion (Actual)

December 15, 2006

Study Registration Dates

First Submitted

June 5, 2007

First Submitted That Met QC Criteria

June 5, 2007

First Posted (Estimate)

June 7, 2007

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIG102335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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