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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    • Inclusion criteria:
    • Body mass index within the range 18.5-29.9 (kg/m2)
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Manchester, Lancashire, United Kingdom, M23 9LT
    Status
    Terminated/Withdrawn
    Contact us

    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
    Study complete
    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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