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The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First QVA149, then Umeclidinium/vilanterol | Experimental | Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. |
|
| First Umeclidinium/vilanterol, then QVA149 | Experimental | Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement. | baseline, 0 to 24 hours post-dose at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement. | baseline, 0 to 24 hours post-dose at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Andalusia | Alabama | 36305 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28993871 | Derived | Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Participants were randomized to 1 of 2 sequences in a 1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | First QVA149, Then Umeclidinium/Vilanterol | Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. |
| FG001 | First Umeclidinium/Vilanterol, Then QVA149 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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|
| Umeclidinium/vilanterol | Drug | Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler |
|
|
| Placebo (umeclidinium/vilanterol) | Drug | Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler |
|
| Placebo (QVA149) | Drug | Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI |
|
| Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment | baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12 |
| Change From Baseline in FEV1 AUC 12-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h). | baseline, 12 hours to 24 hours post-dose at week 12 |
| Change From Baseline in FEV1 AUC 0-12h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h). | baseline, 0 to 12 hours post-dose at week 12 |
| Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h. | baseline, 12 weeks |
| Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment. | baseline, 15 minutes and 45 minutes pre morning dose at week 12 |
| QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | FEV1 was measured with spirometry conducted according to internationally accepted standards. | Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min) |
| QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | FEV1 was measured with spirometry conducted according to internationally accepted standards. | Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min) |
| Anniston |
| Alabama |
| 36207-5710 |
| United States |
| Novartis Investigative Site | Jasper | Alabama | 35501 | United States |
| Novartis Investigative Site | Multiple Locations | Alabama | United States |
| Novartis Investigative Site | Multiple Locations | Arizona | United States |
| Novartis Investigative Site | Tempe | Arizona | 85283 | United States |
| Novartis Investigative Site | Tucson | Arizona | 85723 | United States |
| Novartis Investigative Site | Fayetteville | Arkansas | 72703 | United States |
| Novartis Investigative Site | Huntington Beach | California | 92647 | United States |
| Novartis Investigative Site | Rancho Mirage | California | 92270 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigative Site | Altamonte Springs | Florida | 32701 | United States |
| Novartis Investigative Site | DeLand | Florida | 32720 | United States |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33316-192 | United States |
| Novartis Investigative Site | Kissimmee | Florida | 34741 | United States |
| Novartis Investigative Site | Miami | Florida | 33172 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32503 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32504 | United States |
| Novartis Investigative Site | Port Orange | Florida | 32127 | United States |
| Novartis Investigative Site | Conyers | Georgia | 30094 | United States |
| Novartis Investigative Site | Duluth | Georgia | 30096 | United States |
| Novartis Investigative Site | Meridian | Idaho | 83642 | United States |
| Novartis Investigative Site | New Orleans | Louisiana | 70119 | United States |
| Novartis Investigative Site | Slidell | Louisiana | 70458 | United States |
| Novartis Investigative Site | Sunset | Louisiana | 70584 | United States |
| Novartis Investigative Site | Columbia | Maryland | 21044 | United States |
| Novartis Investigative Site | Edina | Minnesota | 55435 | United States |
| Novartis Investigative Site | Fridley | Minnesota | 55432 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55407 | United States |
| Novartis Investigative Site | Plymouth | Minnesota | 55441 | United States |
| Novartis Investigative Site | Henderson | Nevada | 89014 | United States |
| Novartis Investigative Site | New York | New York | 10016 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Novartis Investigative Site | Cornelius | North Carolina | 28031 | United States |
| Novartis Investigative Site | Gastonia | North Carolina | 28054 | United States |
| Novartis Investigative Site | Hickory | North Carolina | 28602 | United States |
| Novartis Investigative Site | High Point | North Carolina | 27262 | United States |
| Novartis Investigative Site | Huntersville | North Carolina | 28078 | United States |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43213 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43215 | United States |
| Novartis Investigative Site | Dublin | Ohio | 43016 | United States |
| Novartis Investigative Site | Marion | Ohio | 43302 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigative Site | Portland | Oregon | 97213 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19142 | United States |
| Novartis Investigative Site | Tipton | Pennsylvania | 16684 | United States |
| Novartis Investigative Site | Carrollton | Texas | 75010 | United States |
| Novartis Investigative Site | Channelview | Texas | 77530 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76109 | United States |
| Novartis Investigative Site | Lampasas | Texas | 76550 | United States |
| Novartis Investigative Site | McKinney | Texas | 75069 | United States |
| Novartis Investigative Site | New Braunfels | Texas | 78130 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84102 | United States |
| Novartis Investigative Site | Newport News | Virginia | 23606 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout |
|
|
| Period 2 |
|
|
Since this is a cross-over design study, all participants were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. Therefore, the baseline characteristics are reported as overall participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks and Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. |
| 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 |
|
| 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 Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement. | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liters | baseline, 0 to 24 hours post-dose at week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement. | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and post-baseline time point were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liters | baseline, 0 to 24 hours post-dose at week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liters | baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FEV1 AUC 12-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h). | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liters | baseline, 12 hours to 24 hours post-dose at week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FEV1 AUC 0-12h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h). | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liter | baseline, 0 to 12 hours post-dose at week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h | FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h. | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liter | baseline, 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) | FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment. | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liter | baseline, 15 minutes and 45 minutes pre morning dose at week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point | FEV1 was measured with spirometry conducted according to internationally accepted standards. | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liter | Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point | FEV1 was measured with spirometry conducted according to internationally accepted standards. | The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liter | Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min) |
|
|
Not provided
Since this is a cross-over design study, all patients were randomized to receive both treatments, either in sequence QVA/UV or sequence UV/QVA. The number of patients on each treatment does not add up to the total number of patients.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QVA149 | Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. | 13 | 341 | 85 | 341 | ||
| EG001 | Umeclidinium/Vilanterol | Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation b.i.d. for 12 weeks. | 21 | 340 | 104 | 340 | ||
| EG002 | All Patients | All Patients | 33 | 356 | 161 | 356 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | 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 | 862-778-1873 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C554862 | indacaterol-glycopyrronium combination |
| D006024 | Glycopyrrolate |
| C573971 | GSK573719 |
| C550468 | vilanterol |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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