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Status:

COMPLETED

GSK159802 In Healthy Male Subjects And Asthmatics

Lead Sponsor:

GlaxoSmithKline

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

MALE

18+ years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 24 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 6 2006

    Estimated Enrollment :

    43 Patients enrolled

    Trial Details

    Trial ID

    NCT00364273

    Start Date

    August 24 2005

    End Date

    July 6 2006

    Last Update

    September 29 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    GSK Investigational Site

    Manchester, Lancashire, United Kingdom, M23 9LT

    2

    GSK Investigational Site

    London, United Kingdom