Clinical trial NCT00364273: GSK159802 In Healthy Male Subjects And Asthmatics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Safety & tolerability of single inhaled doses of GSK159802.
timeFrame: Up to 71 days
Secondary outcomes:
measure: 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
timeFrame: Up to 71 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: