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To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol and glycopyrronium (QVA149) | Experimental | QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks |
|
| Tiotropium | Active Comparator | Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol and glycopyrronium (QVA149) | Drug | Capsules for inhalation delivered via SDDPI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment | Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment | Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values. | mean of 45 min and 15 min pre-dose week 4 |
| Baseline Transitional Dyspnea Index (TDI) Focal Score |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chuncheon | Gangwon-do | 24253 | South Korea | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28228162 | Derived | Rhee CK, Park HY, Park JW, Lee JH, Kim TH, Lee SW, Jung JY, Kim S, Hwang YI, Jung KS. Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial. Trials. 2017 Feb 22;18(1):80. doi: 10.1186/s13063-017-1800-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol and Glycopyrronium (QVA149) | QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks |
| FG001 | Tiotropium |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2018 | Jun 2, 2019 |
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| Tiotropium | Drug | Capsules for inhalation delivered via HandiHaler® device |
|
A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. TDI captures changes from baseline, each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. |
| Week 12 |
| Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT) | Total score of COPD Assessment Test (CAT) will be measured at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. Mild: Score = 0 - 10, Moderate: Score = 11 - 20, Severe: Score = 21 - 30, Very Severe: Score = 31 - 40. The CAT total score was the sum of 8 item scores (each ranging from 0 to 5). If 1 or 2 items were missing, they were replaced with the mean of the completed items. If 3 or more items were missing, the CAT total score was set missing | Week 12 |
| Daily Rescue Medication Use (Number of Puffs) | The total number of puffs of rescue medication used over the last 24 hours will be recorded in the patient diary in the morning. The total number of puffs of rescue medication per day over the full 12 weeks will be calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient. The mean daily number of puffs of rescue medication used over 12 weeks will be summarized by treatments | Week 12 |
| Wŏnju |
| Gangwon-do |
| 26426 |
| South Korea |
| Novartis Investigative Site | Anyang-si | Gyeonggi-do | 14068 | South Korea |
| Novartis Investigative Site | Guri-si | Gyeonggi-do | 471-701 | South Korea |
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Jeonju | Jeollabuk-do | 561-712 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03312 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06351 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 08308 | South Korea |
| Novartis Investigative Site | Koyang | Kyunggi | 410-719 | South Korea |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Gwangju | 61469 | South Korea |
| Novartis Investigative Site | Incheon | 403-720 | South Korea |
| Novartis Investigative Site | Incheon | 405 760 | South Korea |
| Novartis Investigative Site | Jeju City | 63241 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 04763 | South Korea |
| Novartis Investigative Site | Seoul | 05030 | South Korea |
| Novartis Investigative Site | Seoul | 06273 | South Korea |
| Novartis Investigative Site | Seoul | 110-746 | South Korea |
| Novartis Investigative Site | Seoul | 150-713 | South Korea |
| Novartis Investigative Site | Seoul | 156-707 | South Korea |
| Novartis Investigative Site | Ulsan | 44033 | South Korea |
Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol and Glycopyrronium (QVA149) | QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks |
| BG001 | Tiotropium | Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment | Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values. | The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Mean | Standard Deviation | Liters | Week 12 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment | Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values. | The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Mean | Standard Deviation | Liters | mean of 45 min and 15 min pre-dose week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Transitional Dyspnea Index (TDI) Focal Score | A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. TDI captures changes from baseline, each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. | The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Mean | Standard Deviation | Score | Week 12 |
|
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| Secondary | Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT) | Total score of COPD Assessment Test (CAT) will be measured at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. Mild: Score = 0 - 10, Moderate: Score = 11 - 20, Severe: Score = 21 - 30, Very Severe: Score = 31 - 40. The CAT total score was the sum of 8 item scores (each ranging from 0 to 5). If 1 or 2 items were missing, they were replaced with the mean of the completed items. If 3 or more items were missing, the CAT total score was set missing | The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Number | Number of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Daily Rescue Medication Use (Number of Puffs) | The total number of puffs of rescue medication used over the last 24 hours will be recorded in the patient diary in the morning. The total number of puffs of rescue medication per day over the full 12 weeks will be calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient. The mean daily number of puffs of rescue medication used over 12 weeks will be summarized by treatments | The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Mean | Standard Deviation | Puffs/day | Week 12 |
|
|
12 Weeks
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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 and Glycopyrronium (QVA149 | QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks | 0 | 189 | 8 | 189 | 12 | 189 |
| EG001 | Tiotropium | Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks | 0 | 188 | 3 | 188 | 9 | 188 |
| EG002 | Total | Total | 0 | 377 | 11 | 377 | 21 | 377 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
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 or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 8627788300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2018 | Jun 2, 2019 | SAP_001.pdf |
| 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 |
| D006024 | Glycopyrrolate |
| C554862 | indacaterol-glycopyrronium combination |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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