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A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (INTENSITY)

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ClinicalTrials.gov Identifier: NCT00900731
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : August 19, 2011
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Indacaterol 150 μg
Drug: Tiotropium 18 μg
Drug: Placebo to indacaterol
Drug: Placebo to tiotropium
Enrollment 1598
Recruitment Details  
Pre-assignment Details 1598 participants were randomized. 3 participants in the Indacaterol group and 2 participants in the Tiotropium group did not receive study medication.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Period Title: Overall Study
Started 797 [1] 801
Safety Set: Received Study Drug 794 799
Completed 737 740
Not Completed 60 61
Reason Not Completed
Adverse Event             31             27
Withdrawal by Subject             8             7
Protocol Deviation             8             11
Administrative Problems             5             4
Abnormal Test Procedure Result(s)             3             0
Abnormal Laboratory Value(s)             2             4
Lost to Follow-up             2             3
Lack of Efficacy             1             3
Death             0             2
[1]
Randomized participants
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg Total
Hide Arm/Group Description Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. Total of all reporting groups
Overall Number of Baseline Participants 794 799 1593
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 794 participants 799 participants 1593 participants
63.6  (8.60) 63.4  (8.29) 63.5  (8.45)
[1]
Measure Description: Baseline Measures used the safety population that consisted of all participants who received at least one dose of study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 794 participants 799 participants 1593 participants
Female
239
  30.1%
261
  32.7%
500
  31.4%
Male
555
  69.9%
538
  67.3%
1093
  68.6%
1.Primary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)
Hide Description Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame End of treatment (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population included all participants who received at least one dose of study medication without any major protocol deviations. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data were imputed using last observation carried forward.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 562 595
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1.44  (0.010) 1.43  (0.010)
2.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Hide Description Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame 5 minutes to 4 hours post-dose at the end of treatment (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 685 692
Least Squares Mean (Standard Error)
Unit of Measure: Liter
1.51  (0.010) 1.52  (0.010)
3.Secondary Outcome
Title Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
Hide Description TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 729 737
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
2.01  (0.178) 1.43  (0.178)
4.Secondary Outcome
Title Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Hide Description SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 743 753
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
37.1  (0.56) 39.2  (0.55)
5.Secondary Outcome
Title Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Hide Description Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame Baseline, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 740 747
Least Squares Mean (Standard Error)
Unit of Measure: Puffs
-1.40  (0.097) -0.85  (0.097)
6.Secondary Outcome
Title Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Hide Description Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame Baseline, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 722 732
Least Squares Mean (Standard Error)
Unit of Measure: Puffs
-0.90  (0.063) -0.59  (0.063)
7.Secondary Outcome
Title Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Hide Description Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame Baseline, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 729 742
Least Squares Mean (Standard Error)
Unit of Measure: Puffs
-0.52  (0.043) -0.28  (0.042)
8.Secondary Outcome
Title Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
Hide Description A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.
Arm/Group Title Indacaterol 150 µg Tiotropium 18 µg
Hide Arm/Group Description:
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Overall Number of Participants Analyzed 725 738
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
46.1  (1.65) 41.4  (1.64)
Time Frame 12 weeks
Adverse Event Reporting Description Safety set consisting of all participants who received at least one dose of study drug.
 
Arm/Group Title Indacaterol 150 μg Tiotropium 18 μg
Hide Arm/Group Description Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
All-Cause Mortality
Indacaterol 150 μg Tiotropium 18 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol 150 μg Tiotropium 18 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   22/794 (2.77%)   30/799 (3.75%) 
Cardiac disorders     
Acute coronary syndrome  1  1/794 (0.13%)  0/799 (0.00%) 
Angina pectoris  1  1/794 (0.13%)  0/799 (0.00%) 
Arrhythmia  1  0/794 (0.00%)  2/799 (0.25%) 
Atrial fibrillation  1  0/794 (0.00%)  1/799 (0.13%) 
Cardiac arrest  1  0/794 (0.00%)  1/799 (0.13%) 
Cardiac failure congestive  1  0/794 (0.00%)  1/799 (0.13%) 
Coronary artery disease  1  2/794 (0.25%)  1/799 (0.13%) 
Myocardial infarction  1  1/794 (0.13%)  0/799 (0.00%) 
Myocardial ischaemia  1  1/794 (0.13%)  0/799 (0.00%) 
Eye disorders     
Diabetic eye disease  1  0/794 (0.00%)  1/799 (0.13%) 
Gastrointestinal disorders     
Abdominal pain  1  1/794 (0.13%)  0/799 (0.00%) 
Flatulence  1  1/794 (0.13%)  0/799 (0.00%) 
Gastrooesophageal reflux disease  1  1/794 (0.13%)  0/799 (0.00%) 
Melaena  1  0/794 (0.00%)  1/799 (0.13%) 
Subileus  1  1/794 (0.13%)  0/799 (0.00%) 
Vomiting  1  0/794 (0.00%)  1/799 (0.13%) 
General disorders     
Non-cardiac chest pain  1  0/794 (0.00%)  1/799 (0.13%) 
Immune system disorders     
Hypersensitivity  1  1/794 (0.13%)  0/799 (0.00%) 
Infections and infestations     
Acute sinusitis  1  1/794 (0.13%)  0/799 (0.00%) 
Appendicitis  1  1/794 (0.13%)  0/799 (0.00%) 
Ear infection  1  0/794 (0.00%)  1/799 (0.13%) 
H1N1 influenza  1  2/794 (0.25%)  0/799 (0.00%) 
Influenza  1  0/794 (0.00%)  1/799 (0.13%) 
Lobar pneumonia  1  0/794 (0.00%)  2/799 (0.25%) 
Lower respiratory tract infection  1  1/794 (0.13%)  0/799 (0.00%) 
Pneumococcal sepsis  1  0/794 (0.00%)  1/799 (0.13%) 
Pneumonia  1  3/794 (0.38%)  2/799 (0.25%) 
Septic shock  1  0/794 (0.00%)  1/799 (0.13%) 
Urinary tract infection  1  0/794 (0.00%)  1/799 (0.13%) 
Viral upper respiratory tract infection  1  0/794 (0.00%)  1/799 (0.13%) 
Injury, poisoning and procedural complications     
Anaesthetic complication pulmonary  1  1/794 (0.13%)  0/799 (0.00%) 
Drug toxicity  1  1/794 (0.13%)  0/799 (0.00%) 
Fall  1  1/794 (0.13%)  1/799 (0.13%) 
Foot fracture  1  1/794 (0.13%)  0/799 (0.00%) 
Humerus fracture  1  0/794 (0.00%)  1/799 (0.13%) 
Lumbar vertebral fracture  1  1/794 (0.13%)  0/799 (0.00%) 
Overdose  1  0/794 (0.00%)  1/799 (0.13%) 
Rib fracture  1  0/794 (0.00%)  1/799 (0.13%) 
Investigations     
Fibrin D dimer increased  1  0/794 (0.00%)  1/799 (0.13%) 
Troponin increased  1  1/794 (0.13%)  0/799 (0.00%) 
Metabolism and nutrition disorders     
Metabolic disorder  1  0/794 (0.00%)  1/799 (0.13%) 
Musculoskeletal and connective tissue disorders     
Bursitis  1  0/794 (0.00%)  1/799 (0.13%) 
Costochondritis  1  0/794 (0.00%)  1/799 (0.13%) 
Rheumatoid nodule  1  1/794 (0.13%)  0/799 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/794 (0.00%)  1/799 (0.13%) 
Gallbladder cancer  1  0/794 (0.00%)  1/799 (0.13%) 
Lung adenocarcinoma  1  1/794 (0.13%)  0/799 (0.00%) 
Lung neoplasm malignant  1  0/794 (0.00%)  1/799 (0.13%) 
Nervous system disorders     
Cerebrovascular accident  1  0/794 (0.00%)  2/799 (0.25%) 
Cerebrovascular insufficiency  1  1/794 (0.13%)  0/799 (0.00%) 
Epilepsy  1  0/794 (0.00%)  1/799 (0.13%) 
Syncope  1  1/794 (0.13%)  0/799 (0.00%) 
Vagus nerve paralysis  1  0/794 (0.00%)  1/799 (0.13%) 
Psychiatric disorders     
Alcohol withdrawal syndrome  1  1/794 (0.13%)  0/799 (0.00%) 
Mental status changes  1  0/794 (0.00%)  1/799 (0.13%) 
Renal and urinary disorders     
Nephrotic syndrome  1  0/794 (0.00%)  1/799 (0.13%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  7/794 (0.88%)  6/799 (0.75%) 
Dyspnoea  1  1/794 (0.13%)  3/799 (0.38%) 
Hypoxia  1  1/794 (0.13%)  0/799 (0.00%) 
Pleural effusion  1  1/794 (0.13%)  1/799 (0.13%) 
Pleurisy  1  0/794 (0.00%)  1/799 (0.13%) 
Pulmonary haemorrhage  1  1/794 (0.13%)  0/799 (0.00%) 
Respiratory distress  1  0/794 (0.00%)  1/799 (0.13%) 
Vascular disorders     
Hypertension  1  0/794 (0.00%)  1/799 (0.13%) 
Peripheral arterial occlusive disease  1  0/794 (0.00%)  1/799 (0.13%) 
Peripheral vascular disorder  1  0/794 (0.00%)  1/799 (0.13%) 
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 5%
Indacaterol 150 μg Tiotropium 18 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   80/794 (10.08%)   61/799 (7.63%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  80/794 (10.08%)  61/799 (7.63%) 
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 the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00900731     History of Changes
Other Study ID Numbers: CQAB149B2350
First Submitted: May 12, 2009
First Posted: May 13, 2009
Results First Submitted: July 22, 2011
Results First Posted: August 19, 2011
Last Update Posted: August 19, 2011