Last updated: 11/04/2018 05:40:26

GSK159802 In Healthy Male Subjects And Asthmatics

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GSK study ID
B2F104300
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Clinicaltrials.gov ID
NCT00364273
EudraCT ID
2005-002173-72
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Safety & tolerability of single inhaled doses of GSK159802.

Timeframe: Up to 71 days

Secondary outcomes:

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

Interventions:
Drug: GSK159802
Drug: Placebo
Drug: Salmeterol
Enrollment:
43
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
GSK159802, salbutamol, salmeterol
Collaborators
Not applicable
Study date(s)
August 2005 to July 2006
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18+ years
Accepts healthy volunteers
Yes
  • 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.
  • Any clinically relevant abnormality
  • Subjects who have a screening haemoglobin values < 11 g/dL
Inclusion and exclusion 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
London, United Kingdom
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Terminated/Withdrawn
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-06-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study B2F104300 can be found on the GSK Clinical Study Register.
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