Last updated: 11/07/2018 09:25:13
Long-term Safety study for GSK573719 in JapaneseAC4115361
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with any adverse event (AE) or any serious adverse event (SAE) throughout the treatment period
Timeframe: From the first dose of study medication up to 52 weeks
Number of participants with AEs classified by the indicated maximum grade severity throughout the treatment period
Timeframe: From the first dose of study medication up to 52 weeks
Secondary outcomes:
Basophil, eosinophil, lymphocyte, monocyte, and total neutrophil values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Eosinophil values, total neutrophil values, platelet count, and white blood cell (WBC) count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Hemoglobin, albumin, and total protein values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Hematocrit values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, 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 BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, chloride, glucose, carbon dioxide/bicarbonate (CO2/HCO3), potassium, sodium, inorganic phosphorus, and urea/blood urea nitrogen (Urea/BUN) values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Change from BL in blood pressure throughout the treatment period
Timeframe: BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Change from BL in heart rate throughout the treatment period
Timeframe: BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Number of participants with abnormal findings in 12-lead electrocardiograms (ECG) at the indicated time points
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Interventions:
Drug: GSK573719
Enrollment:
131
Observational study model:
Not applicable
Primary completion date:
2013-19-12
Time perspective:
Not applicable
Clinical publications:
Yamagata E, Soutome T, Hashimoto K, Mihara K, Tohda Y. Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2016;32(5):967-73
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
August 2012 to December 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Inclusion Criteria:
- Outpatient.
Inclusion and exclusion criteria
Inclusion 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 forced expiratory volume/forced vital capacity (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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-19-12
Actual study completion date
2013-19-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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