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Investigation Of A New Medication (GW642444) In Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354874
First received: July 18, 2006
Last updated: September 13, 2016
Last verified: September 2016
July 18, 2006
September 13, 2016
January 2005
June 2005   (Final data collection date for primary outcome measure)
FEV1 at 24 hours after a single dose. [ Time Frame: 24 hours on 4 separate occasions ]
FEV1 at 24 hours after a single dose.
Complete list of historical versions of study NCT00354874 on ClinicalTrials.gov Archive Site
  • FEV1 - Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ]
  • Mean morning/evening PEFR [ Time Frame: Days 3-8 on 4 separate occasions ]
  • BP, HR & QTc on Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ]
  • Potassium and glucose on Days 1 and 7 [ Time Frame: Days 1 and 7 on 4 separate occasions ]
  • safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG [ Time Frame: throughout study ]
  • PK parameters [ Time Frame: Days 1, 4 and 7 on 4 separate occasions ]
FEV1 - Days 1 and 7 Mean morning/evening PEFR BP, HR & QTc on Days 1 and 7 Potassium and glucose on Days 1 and 7 safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG PK parameters
Not Provided
Not Provided
 
Investigation Of A New Medication (GW642444) In Asthmatic Patients
A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444

This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.

Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: GW642444
    drug
  • Drug: Placebo
    placebo
  • Drug: salmeterol 50mcg
    salmeterol
  • Experimental: GW642444 50mcg
    Intervention: Drug: GW642444
  • Experimental: GW642444 100mcg
    Intervention: Drug: GW642444
  • Experimental: GW642444 200mcg
    Intervention: Drug: GW642444
  • Active Comparator: salmeterol 50mcg
    Intervention: Drug: salmeterol 50mcg
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2005
June 2005   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
  • Non-smokers for at least 6 months.
  • Stable asthma.

Exclusion criteria:

  • Abnormal findings on heart monitoring assessment.
  • Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
  • Currently taking doses of fluticasone propionate over 500mcg/day.
  • Unstable asthma medication.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden
 
 
NCT00354874
B2C101762
Not Provided
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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