Long-term Safety Study for GSK573719/GW642444 in Japanese

NCT01376388 | Completed Phase 3 Results

• 1 other identifier: 115362
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 23

Brief Summary

The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary Disease (COPD). This is a multi-centre, open-label study evaluating the safety of GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the morning. The target enrolment is approximately 120 subjects at approximately 20 study centres in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a 7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at screening visit (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2, eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects will be instructed to administer medication once daily in the morning for the duration of the 52-week treatment period. Each subject should be advised to adhere to this dosing regimen throughout the study. There will be a total of 8 study visits including at screening (Visit 1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by the phone contact approximately 1 week following the completion/withdrawal of treatment period. A subject will be considered to have completed the study upon completion of the last on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed appropriate COPD medication at the investigator's discretion.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Pharmacogenetics; GSK573719/GW642444

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period

  An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of \>=5%) and SAEs.

  52 weeks

• Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period

  An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).

  52 weeks

Secondary Outcomes (10)

• Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)

  BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD

  BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD

Study Arms (1)

GSK573719/GW642444

EXPERIMENTAL

125/25mcg

Drug: GSK573719/GW642444 Inhalation Powder

Interventions

GSK573719/GW642444 Inhalation Powder DRUG

GSK573719/GW642444 inhalation powder inhaled orally once daily for 52 weeks.

GSK573719/GW642444

Eligibility Criteria

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

You may qualify if:

• Outpatient.
• A signed and dated written informed consent prior to study participation.
• Japanese subjects 40 years of age or older at screening.
• Male or female subjects (female subjects who have child bearing potential has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used consistently and correctly).
• Diagnosis of COPD.
• pack-year or greater history of cigarette smoking.
• Post-bronchodilator FEV1/FVC of \<0.7.
• Predicted FEV1 of \<80%.

You may not qualify if:

• Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• A current diagnosis of asthma.
• Respiratory disorders other than COPD.
• Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled.
• 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.
• A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition.
• Hospitalization for COPD or pneumonia within 12 weeks prior to screening.
• Subjects with lung volume reduction surgery within the 12 months prior to screening.
• Abnormal and clinically significant ECG findings at screening.
• Significantly abnormal finding from clinical chemistry or hematology, tests at screening.
• 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 via nebulized therapy.
• Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening.
• A know or suspected history of alcohol or drug abuse within 2 years prior to screening.
• Affiliation with the investigational site.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (23)

GSK Investigational Site

Fukuoka, 802-0083, Japan

Location

GSK Investigational Site

Gunma, 371-0048, Japan

Location

GSK Investigational Site

Hiroshima, 732-0052, Japan

Location

GSK Investigational Site

Hiroshima, 732-0057, Japan

Location

GSK Investigational Site

Hokkaido, 064-0915, Japan

Location

GSK Investigational Site

Hokkaido, 080-0805, Japan

Location

GSK Investigational Site

Hyōgo, 665-0827, Japan

Location

GSK Investigational Site

Hyōgo, 670-0849, Japan

Location

GSK Investigational Site

Ibaraki, 300-0053, Japan

Location

GSK Investigational Site

Kagawa, 763-8502, Japan

Location

GSK Investigational Site

Kanagawa, 239-0821, Japan

Location

GSK Investigational Site

Kyoto, 615-8087, Japan

Location

GSK Investigational Site

Osaka, 576-0016, Japan

Location

GSK Investigational Site

Osaka, 589-0022, Japan

Location

GSK Investigational Site

Osaka, 590-0064, Japan

Location

GSK Investigational Site

Ōita, 870-0921, Japan

Location

GSK Investigational Site

Ōita, 876-0047, Japan

Location

GSK Investigational Site

Shizuoka, 436-0022, Japan

Location

GSK Investigational Site

Tokyo, 105-0004, Japan

Location

GSK Investigational Site

Tokyo, 185-0014, Japan

Location

GSK Investigational Site

Tokyo, 187-0024, Japan

Location

GSK Investigational Site

Wakayama, 641-8510, Japan

Location

GSK Investigational Site

Yamanashi, 400-0031, Japan

Location

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

Interventions

GSK573719

Condition Hierarchy (Ancestors)

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

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 20, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 9, 2017
• Results First Posted: March 14, 2014

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (23)