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Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358488
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 27, 2006
First Posted Date  ICMJE July 31, 2006
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE April 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
Mean change from baseline in trough FEV1 [ Time Frame: after 14 day repeat doses ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2006)
Mean change from baseline in trough FEV1 after 14 day repeat doses.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
  • Mean change from baseline in trough FEV1 [ Time Frame: after a single dose ]
  • Mean change from baseline in trough FEV1 [ Time Frame: after 7 days repeat dosing ]
  • Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours [ Time Frame: Day 1 and Day 14 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2006)
Mean change from baseline in trough FEV1 after a single dose Mean change from baseline in trough FEV1 after 7 days repeat dosing Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours Day 1 and Day 14
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Official Title  ICMJE A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797
Brief Summary This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: GSK159797 (10, 15, and 20mcg)
    GSK159797 (10, 15, and 20mcg)
  • Drug: salbutamol
    salbutamol
  • Drug: salmeterol 50mcg
    salmeterol 50mcg
  • Drug: placebo
    placebo
    Other Names:
    • GSK159797 (10
    • 15
    • and 20mcg)
    • salbutamol
    • salmeterol 50mcg
Study Arms  ICMJE
  • Experimental: GSK159797 (10, 15, and 20mcg)
    GSK159797 (10, 15, and 20mcg)
    Intervention: Drug: GSK159797 (10, 15, and 20mcg)
  • Experimental: salbutamol
    salbutamol
    Intervention: Drug: salbutamol
  • Experimental: salmeterol 50mcg
    salmeterol 50mcg
    Intervention: Drug: salmeterol 50mcg
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2007)
54
Original Enrollment  ICMJE
 (submitted: July 27, 2006)
60
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
  • Female subjects only using acceptable birth control method
  • Non-smokers
  • FEV1 between 60 and 90% predicted
  • Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

  • Past or present disease conditions
  • Normal screening Holter ECG
  • Respiratory tract infection within 4 weeks of screening
  • History of life threatening asthma
  • Previous use of COA
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands,   Russian Federation,   Sweden,   United Kingdom
Removed Location Countries New Zealand
 
Administrative Information
NCT Number  ICMJE NCT00358488
Other Study ID Numbers  ICMJE B2E106359
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP