Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Tracking Information
First Submitted Date ICMJE	January 25, 2011
First Posted Date ICMJE	January 28, 2011
Results First Submitted Date	September 4, 2013
Results First Posted Date	November 7, 2013
Last Update Posted Date	December 27, 2013
Study Start Date ICMJE	January 2011
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 8, 2013)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death [ Time Frame: 52 weeks ]; An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.
Original Primary Outcome Measures ICMJE; (submitted: January 26, 2011)	Safety and tolerability of QVA149 with regard to treatment-emergent adverse events [ Time Frame: 52 weeks ]; treatment-emergent adverse events
Change History	Complete list of historical versions of study NCT01285492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 8, 2013)	Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ]Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL; Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period [ Time Frame: 52 weeks ]Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL; Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period [ Time Frame: 52 weeks ]Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.; Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period [ Time Frame: 52 weeks ]Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).; Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline [ Time Frame: Weeks 3, 6, 12, 24, 36, 52 ]Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).; Change in Pre-dose Forced Vital Capacity (FVC) From Baseline [ Time Frame: Weeks 3, 6, 12, 24, 36, 52 ]Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).
Original Secondary Outcome Measures ICMJE; (submitted: January 26, 2011)	Safety of QVA149 as compared with tiotropium with regard to vital signs, electrocardiogram (ECG), and laboratory measurements [ Time Frame: 52 weeks ]vital signs (blood pressure, pulse rate), ECG, laboratory measurements (hematology, urinalysis, clinical chemistry); To assess the safety of QVA149 as compared with tiotropium with regard to study drug discontinuation [ Time Frame: 52 weeks ]Measure: study drug discontinuation
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title ICMJE	A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary	This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Chronic Obstructive Pulmonary Disease (COPD)
Intervention ICMJE	Drug: QVA149 QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1; Drug: Tiotropium Tiotropium (18 μg o.d.), delivered via Handihaler®
Study Arms	Experimental: QVA149 QVA149 110/50 μg once a day (o.d) Intervention: Drug: QVA149; Active Comparator: Tiotropium tiotropium 18 μg o.d. Intervention: Drug: Tiotropium
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 26, 2011)	160
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2012
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.; Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.); Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2. Exclusion Criteria: Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception; Patients requiring long term oxygen therapy; Patients who have had a lower respiratory tract infection within 4 weeks prior to Visit 1; Patients with concomitant pulmonary disease; Patients with a history of asthma; Any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years; Patients with a history of certain cardiovascular comorbid conditions; Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency; Patients in the active phase of a supervised pulmonary rehabilitation program; Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines Other protocol-defined inclusion/exclusion criteria may apply
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Japan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01285492
Other Study ID Numbers ICMJE	CQVA149A1301
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account	Novartis
Verification Date	December 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP