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Trial record 62 of 7513 for:    Area Under Curve

Dose Ranging Study for Indacaterol in Japanese Asthma Patients

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: NCT00403754
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Indacaterol
Drug: Placebo
Drug: Salmeterol
Enrollment 41
Recruitment Details  
Pre-assignment Details A 14 day eligibility screening period insured all participants were stable on their permissible asthma treatment before proceeding onto core study drug treatment.
Arm/Group Title Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol
Hide Arm/Group Description

In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t

In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t

Period Title: Core Treatment Period 1
Started 11 10 9 11
Completed 11 9 9 11
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Period Title: Core Treatment Period 2
Started 11 9 9 11
Completed 11 9 8 11
Not Completed 0 0 1 0
Reason Not Completed
Lack of Efficacy             0             0             1             0
Period Title: Core Treatment Period 3
Started 11 9 8 11
Completed 11 9 8 11
Not Completed 0 0 0 0
Period Title: Core Treatment Period 4
Started 11 9 8 11
Completed 11 9 8 11
Not Completed 0 0 0 0
Period Title: Open Label: Salmeterol
Started 11 9 8 11
Completed 11 9 8 11
Not Completed 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description

The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
47.8  (14.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
21
  51.2%
Male
20
  48.8%
1.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2
Hide Description Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Time Frame 22, 23, and 24 hours post-dose on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.
Arm/Group Title Indacaterol 600 µg Indacaterol 300 µg Indacaterol 150 µg Placebo Salmeterol 100 μg
Hide Arm/Group Description:

Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Overall Number of Participants Analyzed 39 40 40 40 39
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.31  (0.023) 2.28  (0.022) 2.24  (0.022) 2.06  (0.022) 2.23  (0.022)
2.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2
Hide Description Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.
Time Frame 5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.
Arm/Group Title Indacaterol 600 µg Indacaterol 300 µg Indacaterol 150 µg Placebo Salmeterol 100 μg
Hide Arm/Group Description:

Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Overall Number of Participants Analyzed 39 40 40 40 39
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Liters
5 minutes
2.25
(2.22 to 2.27)
2.20
(2.18 to 2.23)
2.19
(2.16 to 2.22)
2.04
(2.01 to 2.07)
2.13
(2.10 to 2.15)
15 minutes
2.33
(2.30 to 2.36)
2.28
(2.25 to 2.32)
2.27
(2.24 to 2.30)
2.05
(2.02 to 2.08)
2.19
(2.16 to 2.22)
30 minutes
2.37
(2.34 to 2.41)
2.33
(2.30 to 2.37)
2.30
(2.27 to 2.34)
2.07
(2.03 to 2.10)
2.24
(2.21 to 2.27)
1 hour
2.41
(2.38 to 2.45)
2.35
(2.32 to 2.38)
2.32
(2.29 to 2.35)
2.09
(2.06 to 2.12)
2.29
(2.25 to 2.32)
2 hours
2.45
(2.41 to 2.48)
2.39
(2.35 to 2.43)
2.38
(2.34 to 2.42)
2.13
(2.09 to 2.16)
2.34
(2.30 to 2.37)
4 hours
2.42
(2.38 to 2.47)
2.39
(2.35 to 2.43)
2.35
(2.31 to 2.39)
2.10
(2.06 to 2.14)
2.34
(2.30 to 2.38)
8 hours
2.37
(2.33 to 2.41)
2.35
(2.31 to 2.38)
2.28
(2.24 to 2.31)
2.06
(2.02 to 2.09)
2.25
(2.21 to 2.29)
12 hours
2.33
(2.28 to 2.37)
2.30
(2.26 to 2.34)
2.24
(2.20 to 2.28)
2.00
(1.96 to 2.05)
2.20
(2.16 to 2.24)
22 hours
2.30
(2.26 to 2.34)
2.25
(2.21 to 2.29)
2.20
(2.16 to 2.24)
2.01
(1.97 to 2.05)
2.18
(2.14 to 2.22)
23 hours
2.32
(2.28 to 2.36)
2.28
(2.25 to 2.32)
2.25
(2.21 to 2.29)
2.06
(2.02 to 2.10)
2.23
(2.20 to 2.27)
24 hours
2.32
(2.28 to 2.35)
2.29
(2.25 to 2.33)
2.26
(2.22 to 2.30)
2.09
(2.06 to 2.13)
2.27
(2.23 to 2.31)
3.Secondary Outcome
Title Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1
Hide Description Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Time Frame 5 minutes to 4 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.
Arm/Group Title Indacaterol 600 µg Indacaterol 300 µg Indacaterol 150 µg Placebo Salmeterol 100 μg
Hide Arm/Group Description:

Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Overall Number of Participants Analyzed 39 40 40 40 39
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.49  (0.018) 2.44  (0.018) 2.41  (0.018) 2.19  (0.18) 2.39  (0.018)
4.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2
Hide Description Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Time Frame 5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.
Arm/Group Title Indacaterol 600 µg Indacaterol 300 µg Indacaterol 150 µg Placebo Salmeterol 100 μg
Hide Arm/Group Description:

Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Overall Number of Participants Analyzed 39 40 40 40 39
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.35  (0.022) 2.31  (0.021) 2.26  (0.021) 2.04  (0.021) 2.24  (0.021)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population included all participants who received at least one dose of study drug.
 
Arm/Group Title Indacaterol 150 μg Indacaterol 300 μg Indacaterol 600 μg Placebo Salmeterol 100 μg
Hide Arm/Group Description

1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
All-Cause Mortality
Indacaterol 150 μg Indacaterol 300 μg Indacaterol 600 μg Placebo Salmeterol 100 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol 150 μg Indacaterol 300 μg Indacaterol 600 μg Placebo Salmeterol 100 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/39 (0.00%)   0/40 (0.00%)   0/39 (0.00%) 
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 Indacaterol 300 μg Indacaterol 600 μg Placebo Salmeterol 100 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/40 (35.00%)   14/40 (35.00%)   14/39 (35.90%)   6/40 (15.00%)   1/39 (2.56%) 
Nervous system disorders           
HEADACHE  1  2/40 (5.00%)  2/40 (5.00%)  1/39 (2.56%)  3/40 (7.50%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders           
COUGH  1  14/40 (35.00%)  13/40 (32.50%)  14/39 (35.90%)  3/40 (7.50%)  0/39 (0.00%) 
OBSTRUCTIVE AIRWAYS DISORDER  1  1/40 (2.50%)  1/40 (2.50%)  2/39 (5.13%)  0/40 (0.00%)  0/39 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00403754     History of Changes
Other Study ID Numbers: CQAB149A1202
First Submitted: November 23, 2006
First Posted: November 27, 2006
Results First Submitted: July 22, 2011
Results First Posted: August 17, 2011
Last Update Posted: August 17, 2011