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This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Indacaterol 300μg followed by Placebo | Experimental | In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
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| Sequence 2 : Placebo followed by Indacaterol 300μg | Experimental | In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 300μg | Drug | 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device |
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| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14 | Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Static Inspiratory Capacity (IC) at Day 14 | Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate, | Day 14 |
| Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Berlin | Germany | ||||
| Novartis Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Indacaterol 300μg Followed by Placebo | In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Placebo | Drug | Matching placebo devices and hard gelatin capsules |
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FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate. |
| Day 14 |
| Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14 | Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate. | Day 14 |
| Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14 | The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect. | Day 1, Day 14 |
| Mönchengladbach |
| Germany |
| Novartis Investigator Site | Wiesbaden | Germany |
| FG001 | Sequence 2 : Placebo Followed by Indacaterol 300μg | In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1: Indacaterol 300μg Followed by Placebo | In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| BG001 | Sequence 2 : Placebo Followed by Indacaterol 300μg | In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Baseline measurements are based on total randomized patients. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14 | Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate. | The safety analysis set consisted of all patients who received study medication and had at least one assessment. | Posted | Least Squares Mean | 90% Confidence Interval | Liters | Day 14 |
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| Secondary | Static Inspiratory Capacity (IC) at Day 14 | Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate, | The safety analysis set consisted of all patients who received study medication and had at least one assessment. | Posted | Least Squares Mean | 90% Confidence Interval | Liters | Day 14 |
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| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14 | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate. | The safety analysis set consisted of all patients who received study medication and had at least one assessment. | Posted | Least Squares Mean | 90% Confidence Interval | Liters | Day 14 |
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| Secondary | Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14 | Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate. | The safety analysis set consisted of all patients who received study medication and had at least one assessment. | Posted | Least Squares Mean | 90% Confidence Interval | Score on a scale | Day 14 |
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| Secondary | Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14 | The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect. | The safety analysis set consisted of all patients who received study medication and had at least one assessment. | Posted | Least Squares Mean | 90% Confidence Interval | Score on a scale | Day 1, Day 14 |
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The safety analysis set that consisted of all patients who received study medication and had at least one assessment.
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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 | Indacaterol 300ug | Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study. | 0 | 26 | 9 | 26 | ||
| EG001 | Placebo | Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study. | 0 | 26 | 9 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.X | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA 10.X | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
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| Tongue coated | Gastrointestinal disorders | MedDRA 10.X | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.X | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 10.X | Systematic Assessment |
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| Electrocardiogram ST segment depression | Investigations | MedDRA 10.X | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 10.X | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
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| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 10.X | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.X | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.X | Systematic Assessment |
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| Nephritis | Renal and urinary disorders | MedDRA 10.X | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA 10.X | Systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
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| Male |
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