Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00463697
First received: April 18, 2007
Last updated: May 31, 2012
Last verified: February 2011

April 18, 2007
May 31, 2012
April 2007
August 2007   (final data collection date for primary outcome measure)
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). [ Time Frame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). ] [ Designated as safety issue: No ]
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Complete list of historical versions of study NCT00463697 on ClinicalTrials.gov Archive Site
Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart). [ Time Frame: Measurements made over 24 hours on 5 occasions (1-2 weeks apart). ] [ Designated as safety issue: No ]
Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Not Provided
Not Provided
 
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients

This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).

Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Asthma
  • Drug: GW642444H (100mcg)
    H salt
  • Drug: placebo
    placebo
  • Drug: GW642444M (25, 100 & 400 mcg)
    M salt
    Other Names:
    • placebo
    • GW642444M (25
    • 100 & 400 mcg)
    • GW642444H (100mcg)
  • Experimental: GW642444M 25mcg
    Intervention: Drug: GW642444M (25, 100 & 400 mcg)
  • Experimental: GW642444M 100mcg
    Intervention: Drug: GW642444M (25, 100 & 400 mcg)
  • Experimental: GW642444M 400mcg
    Intervention: Drug: GW642444M (25, 100 & 400 mcg)
  • Experimental: GW642444H 100mcg
    Intervention: Drug: GW642444H (100mcg)
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • male or female (of non-childbearing potential) between 18 - 70 years
  • History of stable mild to moderate asthma
  • non - smokers
  • currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent)
  • body weight >50 kg with BMI 19-29.9 kg/m2
  • normal ECG assessment

Exclusion criteria:

  • history of significant disease
  • history of life threatening asthma
  • recent respiratory tract infection
  • recent change of asthma medication
  • treatment with high dose inhaled corticosteroids or oral corticosteroids
  • recent participation in another trial
  • history of drug or alcohol abuse
  • known allergies (excluding asthma)
  • recent blood donation
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00463697
B2C106996
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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