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This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QVA149 110/50 micrograms | Experimental | QVA149 110/50 micrograms o.d. Capsules for inhalation |
|
| salmeterol/fluticasone 50/500 micrograms | Active Comparator | salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 110/50 micrograms | Drug | QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Pre-dose FEV1 in Both Arms | Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2). | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Transitional Dyspnea Index (TDI) Focal Score | Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Coffs Harbour | New South Wales | 2450 | Australia | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30074294 | Derived | Frith PA, Ashmawi S, Krishnamurthy S, Gurgun A, Hristoskova S, Pilipovic V, Hamann AM, Backer A, Olsson P, Kostikas K, Diaz DV; FLASH Investigators. Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial. Respirology. 2018 Dec;23(12):1152-1159. doi: 10.1111/resp.13374. Epub 2018 Aug 3. |
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A total of 502 patients were randomized, of which 498 patients were included in the Full Analysis Set (FAS)
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| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 110/50 Micrograms | QVA149 110/50 micrograms o.d. Capsules for inhalation |
| FG001 | Salmeterol/Fluticasone 50/500 Micrograms | salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2017 | Apr 23, 2018 |
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| Salmeterol/fluticasone 50/500 microgrammes | Drug | Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device |
|
| Baseline, week 12 |
| Change From Baseline in FVC (Forced Vital Capacity) | Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1 | week 12 |
| Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test) | The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient. | week 12 |
| Change From Baseline in Mean Daily Use of Rescue Medication | Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement. | over 12 weeks |
| Drummoyne |
| New South Wales |
| 2047 |
| Australia |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Cairns | Queensland | 4870 | Australia |
| Novartis Investigative Site | Daw Park | South Austrailia | 5041 | Australia |
| Novartis Investigative Site | Bedford Park | South Australia | 5042 | Australia |
| Novartis Investigative Site | Glen Osmond | South Australia | 5064 | Australia |
| Novartis Investigative Site | Murdoch | Western Australia | 6150 | Australia |
| Novartis Investigative Site | Al Fayyum | 63514 | Egypt |
| Novartis Investigative Site | Alexandria | 21131 | Egypt |
| Novartis Investigative Site | Cairo | 11566 | Egypt |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 008 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 400 012 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440010 | India |
| Novartis Investigative Site | Mohali | Punjab | 160 062 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641 045 | India |
| Novartis Investigative Site | New Delhi | 110029 | India |
| Novartis Investigative Site | Ashkelon | 78278 | Israel |
| Novartis Investigative Site | Beersheba | 84101 | Israel |
| Novartis Investigative Site | Haifa | 3525408 | Israel |
| Novartis Investigative Site | Jerusalem | 91031 | Israel |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Rehovot | 7610001 | Israel |
| Novartis Investigative Site | Sefad | 13100 | Israel |
| Novartis Investigative Site | Tel Giborim, Holon | 58100 | Israel |
| Novartis Investigative Site | El Chouf | LBN | 1503201002 | Lebanon |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | Beirut | 166378 | Lebanon |
| Novartis Investigative Site | Beirut | 6301 | Lebanon |
| Novartis Investigative Site | El Achrafiyé | 166830 | Lebanon |
| Novartis Investigative Site | Hazmiyeh | 470 | Lebanon |
| Novartis Investigative Site | Saida | 652 | Lebanon |
| Novartis Investigative Site | Kota Bharu | Kelantan | 15586 | Malaysia |
| Novartis Investigative Site | Kuantan | Pahang | 25100 | Malaysia |
| Novartis Investigative Site | Taiping | Perak | 34000 | Malaysia |
| Novartis Investigative Site | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Miri | Sarawak | 98000 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Lipa City | Batangas | 4217 | Philippines |
| Novartis Investigative Site | Bulacan | 3020 | Philippines |
| Novartis Investigative Site | Manila | 1000 | Philippines |
| Novartis Investigative Site | Quezon City | 1100 | Philippines |
| Novartis Investigative Site | San Pablo City, Laguna | 4000 | Philippines |
| Novartis Investigative Site | Riyadh | SAU | 11525 | Saudi Arabia |
| Novartis Investigative Site | Jeddah | 21423 | Saudi Arabia |
| Novartis Investigative Site | Cape Town | 7500 | South Africa |
| Novartis Investigative Site | Durban | 4001 | South Africa |
| Novartis Investigative Site | Gatesville | 7764 | South Africa |
| Novartis Investigative Site | Johannesburg | 2193 | South Africa |
| Novartis Investigative Site | Phoenix | 4068 | South Africa |
| Novartis Investigative Site | Kaoshiung | 83301 | Taiwan |
| Novartis Investigative Site | Linkou District | Taiwan |
| Novartis Investigative Site | New Taipei City | 22060 | Taiwan |
| Novartis Investigative Site | Taichung | 40705 | Taiwan |
| Novartis Investigative Site | Adana | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Aydin | 09100 | Turkey (Türkiye) |
| Novartis Investigative Site | Erzurum | 25240 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34854 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Konya | 42080 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33079 | Turkey (Türkiye) |
| Novartis Investigative Site | Trabzon | 61080 | Turkey (Türkiye) |
| Novartis Investigative Site | Yenisehir/Izmir | 35110 | Turkey (Türkiye) |
| Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to. A total of 502 patients were randomized, of which 498 patients were included in the Full Analysis Set (FAS)
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| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 110/50 Micrograms | QVA149 110/50 micrograms o.d. Capsules for inhalation |
| BG001 | Salmeterol/Fluticasone 50/500 Micrograms | salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder |
| 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 | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to | 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 | Change From Baseline in Trough Pre-dose FEV1 in Both Arms | Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2). | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to | Posted | Least Squares Mean | Standard Error | Liters | Baseline, week 12 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Transitional Dyspnea Index (TDI) Focal Score | Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline. | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FVC (Forced Vital Capacity) | Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1 | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to | Posted | Least Squares Mean | Standard Error | Liters | week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test) | The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient. | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to | Posted | Least Squares Mean | Standard Error | Score on a scale | week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Use of Rescue Medication | Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement. | The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to | Posted | Least Squares Mean | Standard Error | Number of puffs | over 12 weeks |
|
|
All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
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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 | QVA149 | QVA149 110/50 micrograms o.d. Capsules for inhalation | 1 | 248 | 9 | 248 | 39 | 248 |
| EG001 | Salm/Flut | salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder | 1 | 250 | 9 | 250 | 50 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Thalassaemia beta | Congenital, familial and genetic disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hydrocholecystis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neuroendocrine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Penetrating aortic ulcer | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | 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 or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 17, 2015 | Apr 23, 2018 | Prot_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 |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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