This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
415
Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: \<40 bpm or \<= to 50 bpm and a decrease from baseline \>= to 15 bpm. High Pulse Rate was defined as a pulse rate: \>130 bpm or \>= to 120 bpm and an increase from baseline \>= to 15 bpm.
Time frame: Up to 52 weeks
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \<75 mmHg or \<= to 90 mmHg and a decrease from baseline \>= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \>200 mmHg or \>= to 180 mmHg and an increase from baseline \>= to 20 mmHg.
Time frame: Up to 52 weeks
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \<40 mmHg or \<= to 50 mmHg and a decrease from baseline \>= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \>115 mmHg or \>= to 105 mmHg and an increase from baseline \>= to 15 mmHg.
Time frame: Up to 52 weeks
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTC interval= \>450 ms for males and \>470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \>60 ms.
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Novartis Investigative Site
Homewood, Alabama, United States
Novartis Investigative Site
Jasper, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Pine Bluff, Arkansas, United States
Novartis Investigative Site
Encinitas, California, United States
Novartis Investigative SIte
Fullerton, California, United States
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Orange, California, United States
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Riverside, California, United States
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Spring Valley, California, United States
...and 180 more locations
Time frame: Up to 52 weeks
Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52
The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Time frame: Weeks 12, 26, 36, 44 and 52
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52
The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.
Time frame: Weeks 12, 26, 36, 44 and 52
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.
Time frame: Week 52
Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52
The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates. SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.
Time frame: Weeks 36, 44 and 52