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GSK159802 In Healthy Male Subjects And Asthmatics

NCT ID: NCT00364273

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-24

Study Completion Date

2006-07-06

Brief Summary

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GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis.

The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Subjects receiving treatment sequence 1 : Cohort 1

Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 2 : Cohort 1

Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 3 : Cohort 1

Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 4 : Cohort 1

Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 5 : Cohort 1

Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 1 : Cohort 2

Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 2 : Cohort 2

Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 3 : Cohort 2

Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 4 : Cohort 2

Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 1 : Cohort 3

Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 2 : Cohort 3

Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 3 : Cohort 3

Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 4 : Cohort 3

Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Subjects receiving treatment sequence 5 : Cohort 3

Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.

Group Type EXPERIMENTAL

GSK159802

Intervention Type DRUG

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Placebo

Intervention Type DRUG

Subjects will receive placebo administered using DISKUS inhaler.

Salmeterol

Intervention Type DRUG

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Interventions

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GSK159802

GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.

Intervention Type DRUG

Placebo

Subjects will receive placebo administered using DISKUS inhaler.

Intervention Type DRUG

Salmeterol

Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index within the range 18.5-29.9 (kg/m2)
* 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.

Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients):

* Subjects with a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease
* Subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 greater than 60% and less than 90% predicted.

During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \> or equal to 12.0% over baseline and an absolute change of \> or equal to 300 mL within 30 minutes following 400 mcg salbutamol.

Exclusion Criteria

* Any clinically relevant abnormality
* Subjects who have a screening haemoglobin values \< 11 g/dL
* The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days
* Subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Manchester, Lancashire, United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Study Documents

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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B2F104300

Identifier Type: -

Identifier Source: org_study_id