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GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00950807
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : March 4, 2014
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

July 30, 2009
August 3, 2009
January 16, 2014
March 4, 2014
November 8, 2017
September 1, 2009
March 1, 2010   (Final data collection date for primary outcome measure)
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period [ Time Frame: Baseline and Day 15 of each treatment period (up to Study Day 71) ]
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.
Pre-dose (trough) forced expiratory volume in one second (FEV1) [ Time Frame: 15 days ]
Complete list of historical versions of study NCT00950807 on ClinicalTrials.gov Archive Site
  • Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period [ Time Frame: Baseline and Day 14 of each treatment period (TP; up to Study Day 70) ]
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP; mean BL is the mean of the BLs for each participant and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.
  • Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period [ Time Frame: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70) ]
    Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.
  • Serial FEV1 over 28 hours [ Time Frame: 15 days ]
  • Weighted mean FEV1 over 24 hours [ Time Frame: 15 days ]
  • Adverse events [ Time Frame: 15 days ]
  • Vital signs [ Time Frame: 15 days ]
  • ECG measures [ Time Frame: 15 days ]
  • 24 hour Holter monitoring [ Time Frame: 15 days ]
  • Albuterol use [ Time Frame: 15 days ]
  • Clinical chemistry, haematology, and urinalysis assessments [ Time Frame: 15 days ]
Not Provided
Not Provided
 
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects With COPD
The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.
This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Tiotropium
    long-acting muscarinic receptor antagonist; 18mcg once-daily
  • Drug: Placebo
    Inactive/ excipients only
  • Drug: GSK573179
    GSK573179 investigational drug
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Tiotropium
    Tiotropium
    Intervention: Drug: Tiotropium
  • Experimental: Arm 1
    GSK573719 1000mcg once daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 2
    GSK573719 500mcg once daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 3
    GSK573719 250mcg once daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 4
    GSK573719 125mcg once daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 5
    GSK573719 62.5 mcg once daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 6
    GSK573719 250mcg twice daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 7
    GSK573719 125mcg twice daily
    Intervention: Drug: GSK573179
  • Experimental: Arm 8
    GSK573719 62.5mcg twice daily
    Intervention: Drug: GSK573179
Donohue JF, Anzueto A, Brooks J, Mehta R, Kalberg C, Crater G. A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med. 2012 Jul;106(7):970-9. doi: 10.1016/j.rmed.2012.03.012. Epub 2012 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
170
March 15, 2010
March 1, 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A signed and dated written informed consent prior to study participation
  • Males or females of non-childbearing potential
  • 40 to 80 years of age
  • COPD diagnosis
  • 10 pack-years history or greater of cigarette smoking
  • Post-bronchodilator FEV1/FVC ratio of 0.70 or less
  • Post-bronchodilator FEV1 of 35 to 70% of predicted normal

Exclusion Criteria:

  • Asthma
  • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
  • Previous lung resection surgery
  • Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
  • Hospitalization for COPD or pneumonia within 3 months of screening
  • Any significant disease that would put subject at risk through study participation
  • BMI greater than 35
  • Pacemaker
  • Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
  • Cancer
  • Allergy or hypersensitivity to anticholinergics or inhaler excipients
  • Diseases that would contra-indicate the use of anticholinergics
  • Use of oral corticosteroids within 6 weeks of screening
  • Use of long-acting beta-agonists within 48 hours of screening
  • Use of tiotropium within 14 days of screening
  • Use of theophyllines or anti-leukotrienes within 48 hours of screening
  • Use of short-acting bronchodilators within 4 to 6 hours of screening
  • Use of investigational medicines within 30 days of screening
  • Use of high dose inhaled corticosteroids
  • Use of long-term oxygen therapy, CPAP or NIPPV
  • Previous use of GSK573719
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
 
 
NCT00950807
113073
No
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.
URL: http://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2017

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