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This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVA237 | Experimental | 50µg once daily |
|
| Tiotropium | Experimental | 18µg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 | Drug | 50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events or Death | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pre-dose FEV1 From Baseline | Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose. | Weeks 12, 24, 36 and 52 |
| Change in Pre-dose FVC From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-0033 | Japan | ||
| Novartis Investigative Site |
211 participants entered screening. 163 participants entered treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | NVA237 | 50µg once daily |
| FG001 | Tiotropium | 18µg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tiotropium | Drug | 18µg capsules for inhalation, delivered via HandiHaler® |
|
Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.
| Weeks 12, 24, 36 and 52 |
| Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation | Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date. | 52 weeks |
| Number of Patients With Moderate or Severe COPD Exacerbations | Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. | 52 weeks |
| Change in St. George Respiratory Questionnaire From Baseline | SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. | Weeks 12, 24, 36, 52 |
| Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period | Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary. | 52 weeks |
| Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period | 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 | 52 weeks |
| Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period | 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 | 52 weeks |
| Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period | 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. | 52 weeks |
| Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period | Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms). | 52 weeks |
| Iizuka |
| Fukuoka |
| 820-8505 |
| Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 802-0083 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 820-0052 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-0011 | Japan |
| Novartis Investigative Site | Ōnojō | Fukuoka | 816-0931 | Japan |
| Novartis Investigative Site | Yanagawa | Fukuoka | 832-0059 | Japan |
| Novartis Investigative Site | Asahikawa | Hokkaido | 070-8644 | Japan |
| Novartis Investigative Site | Obihiro | Hokkaido | 080-0805 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 672-8064 | Japan |
| Novartis Investigative Site | Takarazuka | Hyōgo | 665-0827 | Japan |
| Novartis Investigative Site | Yabu | Hyōgo | 667-8555 | Japan |
| Novartis Investigative Site | Inashiki-gun | Ibaraki | 300-0395 | Japan |
| Novartis Investigative Site | Naka-gun | Ibaraki | 319-1113 | Japan |
| Novartis Investigative Site | Sashima-gun | Ibaraki | 306-0433 | Japan |
| Novartis Investigative Site | Morioka | Iwate | 020-0055 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 210-0852 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232-0021 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0051 | Japan |
| Novartis Investigative Site | Kochi | Kochi | 780-8077 | Japan |
| Novartis Investigative Site | Uji | Kyoto | 611-0042 | Japan |
| Novartis Investigative Site | Matsusaka | Mie-ken | 515-8544 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 981-8563 | Japan |
| Novartis Investigative Site | Nagaoka | Niigata | 940-2085 | Japan |
| Novartis Investigative Site | Nagaoka | Niigata | 940-8653 | Japan |
| Novartis Investigative Site | Kasaoka | Okayama-ken | 714-0081 | Japan |
| Novartis Investigative Site | Tsuyama | Okayama-ken | 708-0841 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 530-0012 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 591-8555 | Japan |
| Novartis Investigative Site | Sayama | Osaka | 589-0022 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1096 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 337-0012 | Japan |
| Novartis Investigative Site | Shimotsuka-gun | Tochigi | 321-0293 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Nakano-ku | Tokyo | 164-0012 | Japan |
| Novartis Investigative Site | Ohta-ku | Tokyo | 140-0063 | Japan |
| Novartis Investigative Site | Yamagata | Yamagata | 990-8533 | Japan |
| Novartis Investigative Site | Ube | Yamaguchi | 755-0241 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NVA237 | 50µg once daily |
| BG001 | Tiotropium | 18µg once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events, Serious Adverse Events or Death | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. | Safety population - all patients who received at least one dose of study drug | Posted | Number | participants | 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pre-dose FEV1 From Baseline | Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose. | Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint. | Posted | Mean | Standard Deviation | liters | Weeks 12, 24, 36 and 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pre-dose FVC From Baseline | Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose. | Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint. | Posted | Mean | Standard Deviation | liters | Weeks 12, 24, 36 and 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation | Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date. | Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug | Posted | Number | days | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Moderate or Severe COPD Exacerbations | Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. | Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug | Posted | Number | participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in St. George Respiratory Questionnaire From Baseline | SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. | Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint. | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 24, 36, 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period | Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary. | Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug | Posted | Mean | Standard Deviation | change in puffs | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period | 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 | Safety population - all patients who received at least one dose of study drug. Only participants with the required measurements were included for each specific value. | Posted | Number | participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period | 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 | Safety population - all patients who received at least one dose of study drug | Posted | Number | participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period | 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. | Safety population - all patients who received at least one dose of study drug | Posted | Number | participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period | Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms). | Safety population - all patients who received at least one dose of study drug | Posted | Number | participants | 52 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NVA237 | 50µg once daily | 16 | 123 | 83 | 123 | ||
| EG001 | Tiotropium | 18µg once daily | 6 | 40 | 33 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Heat illness | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meniere's disease | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric xanthoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis atrophic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Metaplasia | General disorders | MedDRA | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eczema impetiginous | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
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 the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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