GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

NCT00950807 | Completed Phase 2 Results

• 1 other identifier: 113073
• Study Type: interventional
• Target: 176
• Locations: 2 countries
• Sites: 19

Brief Summary

The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Dose ranging; Chronic Bronchitis; Long-acting muscarinic antagonist; cross-over; COPD; Emphysema; Chronic Obstructive Pulmonary Disease (COPD); anticholinergic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period

  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.

  Baseline and Day 15 of each treatment period (up to Study Day 71)

Secondary Outcomes (2)

• Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period

  Baseline and Day 14 of each treatment period (TP; up to Study Day 70)

• Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period

  Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)

Study Arms (10)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Tiotropium

ACTIVE COMPARATOR

Tiotropium

Drug: Tiotropium

Arm 1

EXPERIMENTAL

GSK573719 1000mcg once daily

Drug: GSK573179

Arm 2

EXPERIMENTAL

GSK573719 500mcg once daily

Drug: GSK573179

Arm 3

EXPERIMENTAL

GSK573719 250mcg once daily

Drug: GSK573179

Arm 4

EXPERIMENTAL

GSK573719 125mcg once daily

Drug: GSK573179

Arm 5

EXPERIMENTAL

GSK573719 62.5 mcg once daily

Drug: GSK573179

Arm 6

EXPERIMENTAL

GSK573719 250mcg twice daily

Drug: GSK573179

Arm 7

EXPERIMENTAL

GSK573719 125mcg twice daily

Drug: GSK573179

Arm 8

EXPERIMENTAL

GSK573719 62.5mcg twice daily

Drug: GSK573179

Interventions

Tiotropium DRUG

long-acting muscarinic receptor antagonist; 18mcg once-daily

Tiotropium

Placebo DRUG

Inactive/ excipients only

Placebo

GSK573179 DRUG

GSK573179 investigational drug

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7; Arm 8

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed and dated written informed consent prior to study participation
• Males or females of non-childbearing potential
• to 80 years of age
• COPD diagnosis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Phoenix, Arizona, 85013, United States

Location

GSK Investigational Site

San Diego, California, 92117, United States

Location

GSK Investigational Site

Upland, California, 91786, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Easley, South Carolina, 29640, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Seneca, South Carolina, 29678, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29379, United States

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Wiesbaden, Hesse, 65187, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 13125, Germany

Location

GSK Investigational Site

Hamburg, 20253, Germany

Location

Related Publications (1)

• 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.

  PMID: 22498110 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 3, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 15, 2010
• Last Updated: November 8, 2017
• Results First Posted: March 4, 2014

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (10); DE (9)