GSK159802 In Healthy Male Subjects And Asthmatics

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364273
• Other study ID #: B2F104300
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2006
• Last updated: September 27, 2017
• Start date: August 24, 2005
• Est. completion date: July 6, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 6, 2006
• Est. primary completion date: July 6, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GSK159802
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
• Placebo
Subjects will receive placebo administered using DISKUS inhaler.
• Salmeterol
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety & tolerability of single inhaled doses of GSK159802.		Up to 71 days
Secondary	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		Up to 71 days

External 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.
•   Results for study B2F104300 can be found on the GSK Clinical Study Register.