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Trial record 65 of 186 for:    GLYCOPYRROLATE

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

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ClinicalTrials.gov Identifier: NCT01285492
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : November 7, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: QVA149
Drug: Tiotropium
Enrollment 160
Recruitment Details 121 patients were randomized to the QVA149 group; however, demographics was on safety set and excluded 2 patients who did not take study drug
Pre-assignment Details There was a pre-screening visit where informed consent was obtained and current COPD medications reviewed and in suitable patients, if necessary, arrangements were made to adjust prohibited COPD therapy to allowable COPD therapy. The interval between Visit 2 and 3 was a 7-days run-in period used to assess eligibility and to collect baseline values.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description QVA149 110/50 μg o.d. (once a day) tiotropium 18 μg o.d.
Period Title: Overall Study
Started 121 [1] 39 [1]
Safety Set (for Demographics) 119 [2] 39 [3]
Completed 104 38
Not Completed 17 1
Reason Not Completed
Adverse Event             11             0
Protocol Violation             3             0
Withdrawal by Subject             2             1
Death             1             0
[1]
All patients randomized to this group
[2]
All patients who took study drug; 2 patients did not
[3]
All patients who took study drug
Arm/Group Title QVA149 Tiotropium Total
Hide Arm/Group Description QVA149 110/50 μg once a day (o.d) tiotropium 18 μg o.d. Total of all reporting groups
Overall Number of Baseline Participants 119 39 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 39 participants 158 participants
69.3  (6.79) 69.4  (6.90) 69.3  (6.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 39 participants 158 participants
Female
5
   4.2%
2
   5.1%
7
   4.4%
Male
114
  95.8%
37
  94.9%
151
  95.6%
Baseline Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 119 participants 39 participants 158 participants
60.38  (9.613) 61.44  (8.788) 60.64  (9.400)
Baseline Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 119 participants 39 participants 158 participants
164.4  (7.08) 163.3  (6.38) 164.1  (6.91)
Baseline Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 119 participants 39 participants 158 participants
22.31  (3.067) 23.02  (2.919) 22.49  (3.037)
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Measure Type: Number
Unit of Measure: Participants
Adverse Events (AEs) 101 28
Serious Advers Events (SAEs) 19 2
Death 1 0
2.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hide Description 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
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Measure Type: Number
Unit of Measure: Participants
Hemoglobin: male (n = 113, 36) 3 0
Hemoglobin: female (n = 5, 2) 0 0
Hematocrit: male (n = 113, 36) 6 0
Hematocrit: female (n = 5, 2) 0 0
White Cell Count < 2800 (n = 118, 38) 0 0
White Cell Count > 2800 (n = 118, 38) 0 0
Platelets < 7.5 (n = 118, 38) 0 0
Platelets > 70.0 (n = 118, 38) 0 0
3.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
Hide Description 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
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Measure Type: Number
Unit of Measure: Participants
Total protein - <4.0 g/dL (n = 118, 38) 0 0
Total protein - > 9.5 g/dL (n = 118, 38) 0 0
albumin <2.5 g/dL (n = 118, 38) 0 0
bilirubin (total) >1.9 mg/dL (n = 118, 38) 0 0
BUN >27 mg/dL (n = 118, 38) 1 0
creatinine >1.99 mg/dL (n = 118, 38) 0 0
AST >3 x ULN U/L (n = 118, 38) 0 0
ALT >3 x ULN U/L (n = 118, 38) 0 0
ALP >3 x ULN U/L (n = 118, 38) 0 0
y-GTP >3 x ULN (n = 118, 38) 2 2
sodium <125 mEq/L (n = 118, 38) 0 0
sodium >160 mEq/L (n = 118, 38) 0 0
potassium <3.0 mEq/ (n = 118, 38) 0 0
potassium >6.0 mEq/ (n = 118, 38) 0 0
glucose <51.0 mg/dL (n = 118, 38) 0 0
glucose >180.0 mg/dL (n = 118, 38) 7 3
4.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Measure Type: Number
Unit of Measure: Participants
Pulse rate: low 0 0
Pulse rate: high 0 0
Pulse rate: low or high 0 0
Systolic blood pressure - low 4 0
Systolic blood pressure - high 0 1
Systolic blood pressure - low or high 4 1
Diastolic blood pressure - low 3 0
Diastolic blood pressure - high 2 1
Diastolic blood pressure - low or high 5 1
5.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia’s QTc Values at Any Time-point Over the Whole Treatment Period
Hide Description Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Measure Type: Number
Unit of Measure: Participants
Males: QTc > 450 ms (n = 111, 36) 6 0
Females: QTc > 470 ms (n = 5, 2) 0 0
Increase from baseline 30 to 60 ms (n = 116, 38) 12 3
Increase from baseline > 60 ms (n = 116, 38) 1 0
6.Secondary Outcome
Title Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Hide Description 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).
Time Frame Weeks 3, 6, 12, 24, 36, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Mean (Standard Deviation)
Unit of Measure: Litres
Week 3 (117, 38) 0.206  (0.1534) 0.093  (0.0977)
Week 6 (115, 38) 0.202  (0.1668) 0.083  (0.1201)
Week 12 (113, 38) 0.209  (0.1725) 0.139  (0.1562)
Week 24 (113, 37) 0.198  (0.1735) 0.115  (0.1400)
Week 36 (105, 37) 0.182  (0.1619) 0.082  (0.1465)
Week 52 (104, 37) 0.189  (0.1762) 0.052  (0.1688)
7.Secondary Outcome
Title Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Hide Description 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).
Time Frame Weeks 3, 6, 12, 24, 36, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description:
QVA149 110/50 μg once a day (o.d)
tiotropium 18 μg o.d.
Overall Number of Participants Analyzed 119 39
Mean (Standard Deviation)
Unit of Measure: Litres
Week 3 (117, 38) 0.314  (0.2882) 0.213  (0.2369)
Week 6 (115, 38) 0.310  (0.3178) 0.173  (0.2162)
Week 12 (113, 38) 0.335  (0.2948) 0.279  (0.2942)
Week 24 (113, 37) 0.330  (0.3248) 0.206  (0.2367)
Week 36 (105, 37) 0.264  (0.2706) 0.167  (0.2438)
Week 52 (104, 37) 0.261  (0.3047) 0.112  (0.2462)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QVA149 Tiotropium
Hide Arm/Group Description QVA149 110/50 μg once a day (o.d) tiotropium 18 μg o.d.
All-Cause Mortality
QVA149 Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QVA149 Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   19/119 (15.97%)   2/39 (5.13%) 
Congenital, familial and genetic disorders     
Arrhythmogenic right ventricular dysplasia  1  1/119 (0.84%)  0/39 (0.00%) 
Gastrointestinal disorders     
Colonic polyp  1  3/119 (2.52%)  0/39 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  2/119 (1.68%)  0/39 (0.00%) 
Cholangitis  1  1/119 (0.84%)  0/39 (0.00%) 
Immune system disorders     
Anaphylactic shock  1  1/119 (0.84%)  0/39 (0.00%) 
Infections and infestations     
Bronchopneumonia  1  1/119 (0.84%)  0/39 (0.00%) 
Cellulitis  1  1/119 (0.84%)  0/39 (0.00%) 
Lower respiratory tract infection  1  1/119 (0.84%)  0/39 (0.00%) 
Pneumonia  1  2/119 (1.68%)  0/39 (0.00%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  1/119 (0.84%)  1/39 (2.56%) 
Metabolism and nutrition disorders     
Dehydration  1  1/119 (0.84%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/119 (0.84%)  0/39 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1  1/119 (0.84%)  0/39 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  1/119 (0.84%)  0/39 (0.00%) 
Thrombotic cerebral infarction  1  1/119 (0.84%)  0/39 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  1/119 (0.84%)  0/39 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/119 (0.84%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  4/119 (3.36%)  0/39 (0.00%) 
Hypoxia  1  1/119 (0.84%)  0/39 (0.00%) 
Pneumothorax  1  0/119 (0.00%)  1/39 (2.56%) 
Respiratory failure  1  1/119 (0.84%)  0/39 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
QVA149 Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   66/119 (55.46%)   23/39 (58.97%) 
Gastrointestinal disorders     
Diarrhoea  1  3/119 (2.52%)  2/39 (5.13%) 
Gastritis  1  0/119 (0.00%)  2/39 (5.13%) 
Infections and infestations     
Bronchitis  1  5/119 (4.20%)  3/39 (7.69%) 
Influenza  1  2/119 (1.68%)  2/39 (5.13%) 
Nasopharyngitis  1  40/119 (33.61%)  12/39 (30.77%) 
Pharyngitis  1  5/119 (4.20%)  1/39 (2.56%) 
Pneumonia  1  7/119 (5.88%)  1/39 (2.56%) 
Upper respiratory tract infection  1  9/119 (7.56%)  6/39 (15.38%) 
Injury, poisoning and procedural complications     
Rib fracture  1  0/119 (0.00%)  3/39 (7.69%) 
Investigations     
Blood alkaline phosphatase increased  1  0/119 (0.00%)  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  6/119 (5.04%)  1/39 (2.56%) 
Nervous system disorders     
Headache  1  4/119 (3.36%)  1/39 (2.56%) 
Psychiatric disorders     
Insomnia  1  4/119 (3.36%)  2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  29/119 (24.37%)  8/39 (20.51%) 
Dysphonia  1  5/119 (4.20%)  1/39 (2.56%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/119 (1.68%)  2/39 (5.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01285492     History of Changes
Other Study ID Numbers: CQVA149A1301
First Submitted: January 25, 2011
First Posted: January 28, 2011
Results First Submitted: September 4, 2013
Results First Posted: November 7, 2013
Last Update Posted: December 27, 2013