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Trial record 30 of 158 for:    Diseases | ( Map: Costa Rica )

Exacerbation Study (INVIGORATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00845728
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Indacaterol 150 µg
Drug: Tiotropium
Enrollment 3439
Recruitment Details 3,444 patients were randomized, but only 3,439 received treatment as 5 patients were mis-randomized.
Pre-assignment Details  
Arm/Group Title Indacaterol Tiotropium
Hide Arm/Group Description

Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.

delivered via the manufacturer’s proprietary inhalation device (Handihaler®)

Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
Period Title: Overall Study
Started 1723 1721
Exposed 1721 1718
Completed 1337 1379
Not Completed 386 342
Reason Not Completed
Abnormal laboratory value (s)             2             2
Patient's inability to use the device             4             6
Abnormal test procedure result (s)             7             2
Lost to Follow-up             22             13
Death             24             26
Administrative Problems             34             26
Protocol Violation             36             24
Lack of Efficacy             51             39
Adverse Event             101             96
Withdrawal by Subject             105             108
Arm/Group Title Indacaterol Tiotropium Total
Hide Arm/Group Description

Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.

delivered via the manufacturer’s proprietary inhalation device (Handihaler®)

Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI Total of all reporting groups
Overall Number of Baseline Participants 1721 1718 3439
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1721 participants 1718 participants 3439 participants
<65 years 929 909 1838
≥ 65 years 792 809 1601
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1721 participants 1718 participants 3439 participants
Female
377
  21.9%
405
  23.6%
782
  22.7%
Male
1344
  78.1%
1313
  76.4%
2657
  77.3%
1.Primary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1).
Hide Description The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.
Arm/Group Title Indacaterol Tiotropium
Hide Arm/Group Description:
Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
Overall Number of Participants Analyzed 1450 1467
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1.134  (0.0008) 1.145  (0.0008)
2.Secondary Outcome
Title Rate of COPD Exacerbations
Hide Description COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.
Arm/Group Title Indacaterol Tiotropium
Hide Arm/Group Description:
Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
Overall Number of Participants Analyzed 1675 1675
Measure Type: Number
Unit of Measure: Exacerbations per patient per year
0.79 0.61
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IndIndacaterol Tiotropium
Hide Arm/Group Description Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
All-Cause Mortality
IndIndacaterol Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IndIndacaterol Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   263/1721 (15.28%)   255/1718 (14.84%) 
Blood and lymphatic system disorders     
Anaemia  1  0/1721 (0.00%)  3/1718 (0.17%) 
Iron deficiency anaemia  1  0/1721 (0.00%)  1/1718 (0.06%) 
Leukopenia  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/1721 (0.06%)  1/1718 (0.06%) 
Acute myocardial infarction  1  3/1721 (0.17%)  2/1718 (0.12%) 
Angina pectoris  1  5/1721 (0.29%)  5/1718 (0.29%) 
Angina unstable  1  0/1721 (0.00%)  1/1718 (0.06%) 
Aortic valve calcification  1  1/1721 (0.06%)  0/1718 (0.00%) 
Arrhythmia  1  3/1721 (0.17%)  1/1718 (0.06%) 
Arrhythmia supraventricular  1  0/1721 (0.00%)  1/1718 (0.06%) 
Arteriosclerosis coronary artery  1  1/1721 (0.06%)  0/1718 (0.00%) 
Atrial fibrillation  1  3/1721 (0.17%)  4/1718 (0.23%) 
Atrial flutter  1  2/1721 (0.12%)  1/1718 (0.06%) 
Atrioventricular block  1  1/1721 (0.06%)  0/1718 (0.00%) 
Atrioventricular block first degree  1  1/1721 (0.06%)  0/1718 (0.00%) 
Bradycardia  1  1/1721 (0.06%)  0/1718 (0.00%) 
Bundle branch block left  1  0/1721 (0.00%)  1/1718 (0.06%) 
Cardiac arrest  1  3/1721 (0.17%)  2/1718 (0.12%) 
Cardiac failure  1  3/1721 (0.17%)  5/1718 (0.29%) 
Cardiac failure chronic  1  1/1721 (0.06%)  1/1718 (0.06%) 
Cardiac failure congestive  1  3/1721 (0.17%)  1/1718 (0.06%) 
Cardio-respiratory arrest  1  3/1721 (0.17%)  2/1718 (0.12%) 
Cardiomegaly  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cardiomyopathy  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cardiopulmonary failure  1  0/1721 (0.00%)  1/1718 (0.06%) 
Congestive cardiomyopathy  1  0/1721 (0.00%)  1/1718 (0.06%) 
Cor pulmonale  1  1/1721 (0.06%)  0/1718 (0.00%) 
Coronary artery disease  1  1/1721 (0.06%)  3/1718 (0.17%) 
Cyanosis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Diastolic dysfunction  1  1/1721 (0.06%)  0/1718 (0.00%) 
Ischaemic cardiomyopathy  1  0/1721 (0.00%)  1/1718 (0.06%) 
Left ventricular hypertrophy  1  1/1721 (0.06%)  0/1718 (0.00%) 
Mitral valve incompetence  1  1/1721 (0.06%)  0/1718 (0.00%) 
Myocardial infarction  1  4/1721 (0.23%)  8/1718 (0.47%) 
Myocardial ischaemia  1  6/1721 (0.35%)  4/1718 (0.23%) 
Palpitations  1  0/1721 (0.00%)  1/1718 (0.06%) 
Right ventricular failure  1  1/1721 (0.06%)  0/1718 (0.00%) 
Sinus bradycardia  1  0/1721 (0.00%)  1/1718 (0.06%) 
Supraventricular extrasystoles  1  0/1721 (0.00%)  1/1718 (0.06%) 
Tachyarrhythmia  1  1/1721 (0.06%)  1/1718 (0.06%) 
Ear and labyrinth disorders     
Hypoacusis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Vertigo  1  0/1721 (0.00%)  1/1718 (0.06%) 
Endocrine disorders     
Goitre  1  1/1721 (0.06%)  0/1718 (0.00%) 
Eye disorders     
Angle closure glaucoma  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cataract  1  1/1721 (0.06%)  1/1718 (0.06%) 
Maculopathy  1  0/1721 (0.00%)  1/1718 (0.06%) 
Retinal vein occlusion  1  0/1721 (0.00%)  1/1718 (0.06%) 
Gastrointestinal disorders     
Abdominal hernia  1  0/1721 (0.00%)  2/1718 (0.12%) 
Abdominal pain  1  0/1721 (0.00%)  2/1718 (0.12%) 
Abdominal pain upper  1  1/1721 (0.06%)  1/1718 (0.06%) 
Acute abdomen  1  0/1721 (0.00%)  1/1718 (0.06%) 
Ascites  1  0/1721 (0.00%)  1/1718 (0.06%) 
Colitis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Colitis ulcerative  1  0/1721 (0.00%)  3/1718 (0.17%) 
Colonic polyp  1  0/1721 (0.00%)  1/1718 (0.06%) 
Constipation  1  1/1721 (0.06%)  3/1718 (0.17%) 
Diarrhoea  1  1/1721 (0.06%)  1/1718 (0.06%) 
Diverticulum  1  1/1721 (0.06%)  0/1718 (0.00%) 
Duodenal fistula  1  1/1721 (0.06%)  0/1718 (0.00%) 
Duodenitis  1  0/1721 (0.00%)  2/1718 (0.12%) 
Enteritis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Gastric ulcer  1  0/1721 (0.00%)  2/1718 (0.12%) 
Gastritis  1  1/1721 (0.06%)  1/1718 (0.06%) 
Gastrooesophageal reflux disease  1  0/1721 (0.00%)  2/1718 (0.12%) 
Haematemesis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Ileus  1  1/1721 (0.06%)  0/1718 (0.00%) 
Inguinal hernia  1  1/1721 (0.06%)  1/1718 (0.06%) 
Intestinal ischaemia  1  0/1721 (0.00%)  1/1718 (0.06%) 
Intestinal obstruction  1  3/1721 (0.17%)  0/1718 (0.00%) 
Mallory-Weiss syndrome  1  1/1721 (0.06%)  0/1718 (0.00%) 
Melaena  1  0/1721 (0.00%)  1/1718 (0.06%) 
Nausea  1  2/1721 (0.12%)  0/1718 (0.00%) 
Oesophagitis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Pancreatitis  1  0/1721 (0.00%)  3/1718 (0.17%) 
Pancreatitis acute  1  0/1721 (0.00%)  2/1718 (0.12%) 
Regurgitation  1  1/1721 (0.06%)  0/1718 (0.00%) 
Sigmoiditis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Small intestinal obstruction  1  0/1721 (0.00%)  1/1718 (0.06%) 
Thrombosis mesenteric vessel  1  1/1721 (0.06%)  0/1718 (0.00%) 
Umbilical hernia  1  1/1721 (0.06%)  0/1718 (0.00%) 
Upper gastrointestinal haemorrhage  1  2/1721 (0.12%)  1/1718 (0.06%) 
General disorders     
Chills  1  1/1721 (0.06%)  0/1718 (0.00%) 
Death  1  1/1721 (0.06%)  1/1718 (0.06%) 
Device dislocation  1  1/1721 (0.06%)  0/1718 (0.00%) 
Drug ineffective  1  0/1721 (0.00%)  1/1718 (0.06%) 
Malaise  1  1/1721 (0.06%)  0/1718 (0.00%) 
Multi-organ failure  1  0/1721 (0.00%)  1/1718 (0.06%) 
Non-cardiac chest pain  1  4/1721 (0.23%)  1/1718 (0.06%) 
Oedema due to cardiac disease  1  0/1721 (0.00%)  1/1718 (0.06%) 
Oedema peripheral  1  2/1721 (0.12%)  1/1718 (0.06%) 
Pyrexia  1  3/1721 (0.17%)  1/1718 (0.06%) 
Soft tissue inflammation  1  1/1721 (0.06%)  0/1718 (0.00%) 
Sudden cardiac death  1  0/1721 (0.00%)  1/1718 (0.06%) 
Sudden death  1  1/1721 (0.06%)  1/1718 (0.06%) 
Hepatobiliary disorders     
Bile duct stone  1  0/1721 (0.00%)  1/1718 (0.06%) 
Cholangitis acute  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cholecystitis  1  0/1721 (0.00%)  2/1718 (0.12%) 
Cholelithiasis  1  1/1721 (0.06%)  2/1718 (0.12%) 
Gallbladder fistula  1  1/1721 (0.06%)  0/1718 (0.00%) 
Hepatic function abnormal  1  1/1721 (0.06%)  0/1718 (0.00%) 
Hyperbilirubinaemia  1  0/1721 (0.00%)  1/1718 (0.06%) 
Jaundice  1  0/1721 (0.00%)  1/1718 (0.06%) 
Immune system disorders     
Drug hypersensitivity  1  1/1721 (0.06%)  0/1718 (0.00%) 
Infections and infestations     
Anal abscess  1  1/1721 (0.06%)  0/1718 (0.00%) 
Appendicitis perforated  1  0/1721 (0.00%)  1/1718 (0.06%) 
Bronchitis  1  3/1721 (0.17%)  2/1718 (0.12%) 
Bronchitis bacterial  1  1/1721 (0.06%)  1/1718 (0.06%) 
Bronchopneumonia  1  2/1721 (0.12%)  3/1718 (0.17%) 
Clostridial infection  1  0/1721 (0.00%)  1/1718 (0.06%) 
Diverticulitis  1  1/1721 (0.06%)  2/1718 (0.12%) 
Gastroenteritis  1  0/1721 (0.00%)  2/1718 (0.12%) 
H1N1 influenza  1  1/1721 (0.06%)  0/1718 (0.00%) 
Helicobacter infection  1  0/1721 (0.00%)  1/1718 (0.06%) 
Herpes zoster  1  1/1721 (0.06%)  4/1718 (0.23%) 
Influenza  1  4/1721 (0.23%)  2/1718 (0.12%) 
Intervertebral discitis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lobar pneumonia  1  4/1721 (0.23%)  4/1718 (0.23%) 
Lower respiratory tract infection  1  28/1721 (1.63%)  18/1718 (1.05%) 
Lower respiratory tract infection bacterial  1  4/1721 (0.23%)  2/1718 (0.12%) 
Lower respiratory tract infection viral  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung abscess  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung infection  1  0/1721 (0.00%)  2/1718 (0.12%) 
Meningitis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Meningitis viral  1  0/1721 (0.00%)  1/1718 (0.06%) 
Nasopharyngitis  1  3/1721 (0.17%)  3/1718 (0.17%) 
Oral candidiasis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Pneumococcal sepsis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Pneumonia  1  29/1721 (1.69%)  24/1718 (1.40%) 
Pneumonia bacterial  1  1/1721 (0.06%)  2/1718 (0.12%) 
Pneumonia pneumococcal  1  1/1721 (0.06%)  0/1718 (0.00%) 
Pneumonia staphylococcal  1  0/1721 (0.00%)  1/1718 (0.06%) 
Pseudomonas infection  1  1/1721 (0.06%)  0/1718 (0.00%) 
Pulmonary tuberculosis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Respiratory tract infection bacterial  1  0/1721 (0.00%)  1/1718 (0.06%) 
Respiratory tract infection viral  1  1/1721 (0.06%)  0/1718 (0.00%) 
Sepsis  1  0/1721 (0.00%)  2/1718 (0.12%) 
Septic shock  1  1/1721 (0.06%)  3/1718 (0.17%) 
Sinusitis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Testicular abscess  1  0/1721 (0.00%)  1/1718 (0.06%) 
Tracheobronchitis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Upper respiratory tract infection  1  3/1721 (0.17%)  2/1718 (0.12%) 
Upper respiratory tract infection bacterial  1  18/1721 (1.05%)  16/1718 (0.93%) 
Urinary tract infection  1  1/1721 (0.06%)  2/1718 (0.12%) 
Urosepsis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Viral sepsis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Viral upper respiratory tract infection  1  12/1721 (0.70%)  11/1718 (0.64%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/1721 (0.00%)  2/1718 (0.12%) 
Concussion  1  1/1721 (0.06%)  0/1718 (0.00%) 
Contusion  1  0/1721 (0.00%)  1/1718 (0.06%) 
Fall  1  2/1721 (0.12%)  1/1718 (0.06%) 
Femoral neck fracture  1  1/1721 (0.06%)  2/1718 (0.12%) 
Femur fracture  1  1/1721 (0.06%)  1/1718 (0.06%) 
Hip fracture  1  0/1721 (0.00%)  2/1718 (0.12%) 
Penetrating abdominal trauma  1  0/1721 (0.00%)  1/1718 (0.06%) 
Post procedural fistula  1  1/1721 (0.06%)  0/1718 (0.00%) 
Rib fracture  1  2/1721 (0.12%)  1/1718 (0.06%) 
Tibia fracture  1  1/1721 (0.06%)  0/1718 (0.00%) 
Traumatic shock  1  0/1721 (0.00%)  1/1718 (0.06%) 
Investigations     
Arteriogram coronary  1  0/1721 (0.00%)  1/1718 (0.06%) 
C-reactive protein increased  1  1/1721 (0.06%)  0/1718 (0.00%) 
Prostatic specific antigen increased  1  0/1721 (0.00%)  1/1718 (0.06%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/1721 (0.00%)  1/1718 (0.06%) 
Diabetes mellitus  1  1/1721 (0.06%)  0/1718 (0.00%) 
Diabetes mellitus inadequate control  1  1/1721 (0.06%)  0/1718 (0.00%) 
Hyperkalaemia  1  2/1721 (0.12%)  0/1718 (0.00%) 
Hyponatraemia  1  0/1721 (0.00%)  1/1718 (0.06%) 
Musculoskeletal and connective tissue disorders     
Axillary mass  1  1/1721 (0.06%)  0/1718 (0.00%) 
Back pain  1  4/1721 (0.23%)  0/1718 (0.00%) 
Cervical spinal stenosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Exostosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Intervertebral disc degeneration  1  1/1721 (0.06%)  1/1718 (0.06%) 
Intervertebral disc disorder  1  1/1721 (0.06%)  0/1718 (0.00%) 
Intervertebral disc protrusion  1  1/1721 (0.06%)  0/1718 (0.00%) 
Musculoskeletal chest pain  1  1/1721 (0.06%)  0/1718 (0.00%) 
Musculoskeletal pain  1  1/1721 (0.06%)  0/1718 (0.00%) 
Myalgia  1  1/1721 (0.06%)  0/1718 (0.00%) 
Neck pain  1  1/1721 (0.06%)  0/1718 (0.00%) 
Osteonecrosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Rotator cuff syndrome  1  1/1721 (0.06%)  0/1718 (0.00%) 
Spinal column stenosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Spinal osteoarthritis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign neoplasm of prostate  1  1/1721 (0.06%)  0/1718 (0.00%) 
Bladder cancer  1  1/1721 (0.06%)  0/1718 (0.00%) 
Bladder papilloma  1  1/1721 (0.06%)  0/1718 (0.00%) 
Breast cancer  1  0/1721 (0.00%)  2/1718 (0.12%) 
Bronchial carcinoma  1  1/1721 (0.06%)  0/1718 (0.00%) 
Colon adenoma  1  2/1721 (0.12%)  0/1718 (0.00%) 
Colon cancer  1  2/1721 (0.12%)  1/1718 (0.06%) 
Colon neoplasm  1  0/1721 (0.00%)  1/1718 (0.06%) 
Gallbladder cancer  1  1/1721 (0.06%)  0/1718 (0.00%) 
Gastric cancer  1  0/1721 (0.00%)  2/1718 (0.12%) 
Glioblastoma  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung adenocarcinoma  1  1/1721 (0.06%)  1/1718 (0.06%) 
Lung cancer metastatic  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung neoplasm  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung neoplasm malignant  1  4/1721 (0.23%)  5/1718 (0.29%) 
Metastases to central nervous system  1  1/1721 (0.06%)  0/1718 (0.00%) 
Metastases to peritoneum  1  0/1721 (0.00%)  1/1718 (0.06%) 
Myelofibrosis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Neoplasm malignant  1  0/1721 (0.00%)  1/1718 (0.06%) 
Neoplasm prostate  1  1/1721 (0.06%)  0/1718 (0.00%) 
Ovarian cancer  1  1/1721 (0.06%)  1/1718 (0.06%) 
Pancreatic carcinoma  1  0/1721 (0.00%)  2/1718 (0.12%) 
Prostate cancer  1  3/1721 (0.17%)  1/1718 (0.06%) 
Prostatic adenoma  1  1/1721 (0.06%)  1/1718 (0.06%) 
Rectal cancer  1  1/1721 (0.06%)  0/1718 (0.00%) 
Rectal neoplasm  1  0/1721 (0.00%)  1/1718 (0.06%) 
Renal cancer  1  1/1721 (0.06%)  1/1718 (0.06%) 
Salivary gland adenoma  1  1/1721 (0.06%)  0/1718 (0.00%) 
Squamous cell carcinoma of skin  1  1/1721 (0.06%)  0/1718 (0.00%) 
Nervous system disorders     
Amyotrophic lateral sclerosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Brain injury  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cerebral haemorrhage  1  0/1721 (0.00%)  1/1718 (0.06%) 
Cerebral infarction  1  2/1721 (0.12%)  1/1718 (0.06%) 
Cerebral ischaemia  1  1/1721 (0.06%)  1/1718 (0.06%) 
Cerebral thrombosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Cerebrovascular accident  1  2/1721 (0.12%)  1/1718 (0.06%) 
Coma  1  1/1721 (0.06%)  0/1718 (0.00%) 
Depressed level of consciousness  1  0/1721 (0.00%)  1/1718 (0.06%) 
Dizziness  1  1/1721 (0.06%)  0/1718 (0.00%) 
Grand mal convulsion  1  1/1721 (0.06%)  0/1718 (0.00%) 
Haemorrhage intracranial  1  0/1721 (0.00%)  1/1718 (0.06%) 
Headache  1  2/1721 (0.12%)  0/1718 (0.00%) 
Hypoglycaemic coma  1  1/1721 (0.06%)  0/1718 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  0/1721 (0.00%)  1/1718 (0.06%) 
Intracranial aneurysm  1  0/1721 (0.00%)  1/1718 (0.06%) 
Ischaemic stroke  1  2/1721 (0.12%)  0/1718 (0.00%) 
Lacunar infarction  1  1/1721 (0.06%)  0/1718 (0.00%) 
Memory impairment  1  0/1721 (0.00%)  1/1718 (0.06%) 
Peripheral sensorimotor neuropathy  1  1/1721 (0.06%)  0/1718 (0.00%) 
Peripheral sensory neuropathy  1  0/1721 (0.00%)  1/1718 (0.06%) 
Presyncope  1  1/1721 (0.06%)  0/1718 (0.00%) 
Sensory loss  1  1/1721 (0.06%)  0/1718 (0.00%) 
Spinal cord compression  1  1/1721 (0.06%)  0/1718 (0.00%) 
Syncope  1  1/1721 (0.06%)  1/1718 (0.06%) 
Transient ischaemic attack  1  2/1721 (0.12%)  4/1718 (0.23%) 
Vascular encephalopathy  1  1/1721 (0.06%)  0/1718 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/1721 (0.00%)  2/1718 (0.12%) 
Completed suicide  1  0/1721 (0.00%)  2/1718 (0.12%) 
Confusional state  1  1/1721 (0.06%)  1/1718 (0.06%) 
Depression  1  0/1721 (0.00%)  1/1718 (0.06%) 
Renal and urinary disorders     
Bladder neck obstruction  1  0/1721 (0.00%)  1/1718 (0.06%) 
Haematuria  1  2/1721 (0.12%)  0/1718 (0.00%) 
Nephrotic syndrome  1  0/1721 (0.00%)  1/1718 (0.06%) 
Renal failure  1  1/1721 (0.06%)  0/1718 (0.00%) 
Renal failure acute  1  3/1721 (0.17%)  0/1718 (0.00%) 
Urethral stenosis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Urinary retention  1  1/1721 (0.06%)  1/1718 (0.06%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/1721 (0.12%)  3/1718 (0.17%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/1721 (0.00%)  1/1718 (0.06%) 
Acute respiratory failure  1  4/1721 (0.23%)  2/1718 (0.12%) 
Apnoea  1  1/1721 (0.06%)  0/1718 (0.00%) 
Chronic obstructive pulmonary disease  1  147/1721 (8.54%)  121/1718 (7.04%) 
Cough  1  1/1721 (0.06%)  0/1718 (0.00%) 
Dyspnoea  1  12/1721 (0.70%)  4/1718 (0.23%) 
Haemoptysis  1  1/1721 (0.06%)  1/1718 (0.06%) 
Hydrothorax  1  0/1721 (0.00%)  2/1718 (0.12%) 
Hypercapnia  1  2/1721 (0.12%)  1/1718 (0.06%) 
Hypoxia  1  1/1721 (0.06%)  0/1718 (0.00%) 
Interstitial lung disease  1  1/1721 (0.06%)  0/1718 (0.00%) 
Laryngeal oedema  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung disorder  1  0/1721 (0.00%)  1/1718 (0.06%) 
Lung infiltration  1  1/1721 (0.06%)  0/1718 (0.00%) 
Oropharyngeal pain  1  1/1721 (0.06%)  0/1718 (0.00%) 
Pleural effusion  1  1/1721 (0.06%)  0/1718 (0.00%) 
Pleurisy  1  2/1721 (0.12%)  2/1718 (0.12%) 
Pneumonia aspiration  1  0/1721 (0.00%)  1/1718 (0.06%) 
Pneumothorax  1  4/1721 (0.23%)  2/1718 (0.12%) 
Productive cough  1  0/1721 (0.00%)  1/1718 (0.06%) 
Pulmonary embolism  1  1/1721 (0.06%)  3/1718 (0.17%) 
Pulmonary oedema  1  2/1721 (0.12%)  0/1718 (0.00%) 
Respiratory acidosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Respiratory failure  1  4/1721 (0.23%)  6/1718 (0.35%) 
Sleep apnoea syndrome  1  0/1721 (0.00%)  1/1718 (0.06%) 
Sputum increased  1  0/1721 (0.00%)  1/1718 (0.06%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/1721 (0.06%)  0/1718 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  2/1721 (0.12%)  0/1718 (0.00%) 
Aortic stenosis  1  2/1721 (0.12%)  0/1718 (0.00%) 
Circulatory collapse  1  0/1721 (0.00%)  1/1718 (0.06%) 
Deep vein thrombosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Hypertension  1  2/1721 (0.12%)  1/1718 (0.06%) 
Hypertensive crisis  1  1/1721 (0.06%)  1/1718 (0.06%) 
Hypertensive emergency  1  1/1721 (0.06%)  0/1718 (0.00%) 
Hypotension  1  0/1721 (0.00%)  1/1718 (0.06%) 
Peripheral arterial occlusive disease  1  0/1721 (0.00%)  1/1718 (0.06%) 
Peripheral artery stenosis  1  1/1721 (0.06%)  0/1718 (0.00%) 
Peripheral ischaemia  1  0/1721 (0.00%)  1/1718 (0.06%) 
Phlebitis  1  0/1721 (0.00%)  1/1718 (0.06%) 
Varicose vein  1  0/1721 (0.00%)  1/1718 (0.06%) 
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 1.5%
IndIndacaterol Tiotropium
Affected / at Risk (%) Affected / at Risk (%)
Total   890/1721 (51.71%)   793/1718 (46.16%) 
Gastrointestinal disorders     
Diarrhoea  1  26/1721 (1.51%)  43/1718 (2.50%) 
General disorders     
Pyrexia  1  19/1721 (1.10%)  26/1718 (1.51%) 
Infections and infestations     
Bronchitis  1  39/1721 (2.27%)  34/1718 (1.98%) 
Influenza  1  38/1721 (2.21%)  45/1718 (2.62%) 
Lower respiratory tract infection  1  125/1721 (7.26%)  98/1718 (5.70%) 
Nasopharyngitis  1  118/1721 (6.86%)  101/1718 (5.88%) 
Upper respiratory tract infection  1  70/1721 (4.07%)  63/1718 (3.67%) 
Upper respiratory tract infection bacterial  1  139/1721 (8.08%)  127/1718 (7.39%) 
Urinary tract infection  1  31/1721 (1.80%)  26/1718 (1.51%) 
Viral upper respiratory tract infection  1  91/1721 (5.29%)  65/1718 (3.78%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  39/1721 (2.27%)  40/1718 (2.33%) 
Nervous system disorders     
Headache  1  53/1721 (3.08%)  49/1718 (2.85%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  668/1721 (38.81%)  591/1718 (34.40%) 
Cough  1  107/1721 (6.22%)  56/1718 (3.26%) 
Dyspnoea  1  56/1721 (3.25%)  50/1718 (2.91%) 
Vascular disorders     
Hypertension  1  63/1721 (3.66%)  48/1718 (2.79%) 
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.

Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI 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.

Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00845728     History of Changes
Other Study ID Numbers: CQAB149B2348
2008-007944-33
First Submitted: February 15, 2009
First Posted: February 18, 2009
Results First Submitted: July 3, 2013
Results First Posted: November 19, 2013
Last Update Posted: November 19, 2013