We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

GSK159802 In Healthy Male Subjects And Asthmatics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364273
First Posted: August 15, 2006
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: GSK159802 Drug: Placebo Drug: Salmeterol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Profile of Single Inhaled Dry Powder Doses of GSK159802 in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety & tolerability of single inhaled doses of GSK159802. [ Time Frame: Up to 71 days ]

Secondary Outcome Measures:
  • sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure [ Time Frame: Up to 71 days ]

Enrollment: 43
Actual Study Start Date: August 24, 2005
Study Completion Date: July 6, 2006
Primary Completion Date: July 6, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: 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.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: 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.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: 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.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: 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.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Experimental: Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
Drug: GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Drug: Placebo
Subjects will receive placebo administered using DISKUS inhaler.
Drug: Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364273


Locations
United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
GSK Investigational Site
London, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: B2F104300
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00364273     History of Changes
Other Study ID Numbers: B2F104300
First Submitted: August 11, 2006
First Posted: August 15, 2006
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
Asthma

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action