Long-term Safety Study for GSK573719 in Japanese (AC4115361)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01702363
First received: September 20, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: GSK573719
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 52-week, Multi-centre, Open-label Study to Evaluate the Safety and Tolerability of GSK573719 125 Mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Japanese Subjects With Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Over the 52-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in clinical laboratory data (hematology, clinical chemistry) [ Time Frame: Week 12, 24, 36, and 52 ] [ Designated as safety issue: No ]
  • Change from baseline in vital signs (pulse rate and systolic and diastolic pressure) [ Time Frame: Week 0, 4, 8, 12, 24, 36, and 52 ] [ Designated as safety issue: No ]
  • Frequency of abnormal findings of 12-lead ECG [ Time Frame: Week 12, 24, 36, and 52 ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK573719
125mcg
Drug: GSK573719
GSK573719 inhalation powder inhaled orally once daily for 52 weeks.

Detailed Description:

Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental approach to pharmacological treatment as the disease state worsens, involving the use of combinations of drug classes with different or complementary mechanisms of action [Celli, 2004, GOLD 2009]. As disease progresses from mild to moderate, regular treatment with one or more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2 agonists and anticholinergics are included with ICS therapy and are mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is expected to be used for chronic management of COPD as long-acting muscarinic antagonist (LAMA), this study is intended to evaluate the safety and tolerability of long-term administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses possibly used to be in Japan.

In this study, patient safety will also be monitored by evaluating pulmonary function and clinical symptoms.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient.
  • A signed and dated written informed consent prior to study participation.
  • Japanese subjects 40 years of age or older at Visit 1.
  • Male or female subjects. A female is eligible if she is of: Non-child bearing potential or Child bearing potential agrees to one of the contraceptive methods.
  • Subjects with a clinical history of COPD in accordance with the definition by COPD domestic guideline.
  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Visit 1.
  • Subject with a measured post-salbutamol FEV1/FVC ratio of <70% and Subjects with a measured post-salbutamol FEV1 <80% of predicted normal values.

Exclusion Criteria (Visit 1):

  • Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • A current diagnosis of asthma.
  • Known respiratory disorders other than COPD.
  • Subjects with historical or current evidence of clinically significant abnormalities that are uncontrolled.
  • A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
  • Allergy or hypersensitivity to muscarinic, beta2-agonist, lactose/milk protein or magnesium stearate or a condition that contraindicates participation.
  • Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
  • Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
  • An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1.
  • Significantly abnormal finding from clinical chemistry or hematology, tests at Visit 1.
  • Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day.
  • Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
  • A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with Investigator Site.
  • Previous use of GSK573719, the GSK573719/GW642444 combination.
  • Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer).

Exclusion Criteria (Visit 2):

- COPD Exacerbation during run-in period: Subject must not have experienced a COPD exacerbation or a lower respiratory tract infection during run-in or at Visit 2.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702363

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 811-1347
GSK Investigational Site
Gunma, Japan, 371-0048
GSK Investigational Site
Hokkaido, Japan, 080-0805
GSK Investigational Site
Hyogo, Japan, 670-0849
GSK Investigational Site
Ibaraki, Japan, 302-0022
GSK Investigational Site
Ibaraki, Japan, 300-0053
GSK Investigational Site
Ishikawa, Japan, 920-8610
GSK Investigational Site
Kanagawa, Japan, 239-0821
GSK Investigational Site
Kyoto, Japan, 601-1495
GSK Investigational Site
Miyagi, Japan, 983-0824
GSK Investigational Site
Nagano, Japan, 391-0011
GSK Investigational Site
Oita, Japan, 870-0921
GSK Investigational Site
Oita, Japan, 876-0047
GSK Investigational Site
Osaka, Japan, 589-0022
GSK Investigational Site
Osaka, Japan, 530-0001
GSK Investigational Site
Shizuoka, Japan, 436-0022
GSK Investigational Site
Tokyo, Japan, 153-8934
GSK Investigational Site
Tokyo, Japan, 103-0027
GSK Investigational Site
Tokyo, Japan, 192-0903
GSK Investigational Site
Yamanashi, Japan, 400-0031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01702363     History of Changes
Other Study ID Numbers: 115361
Study First Received: September 20, 2012
Last Updated: January 9, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014