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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004223-37 | EudraCT Number |
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The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 |
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| Treatment sequence 2 | Experimental | Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation | Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire. | Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ibbenbüren | Rhineland-Palatinate | 49477 | Germany | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 | QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 |
| FG001 | Treatment Sequence 2 | Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Tiotropium | Drug | Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day |
|
| Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions. |
The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire |
| 8 weeks |
| Berlin |
| 12203 |
| Germany |
| Novartis Investigative Site | Berlin | 13057 | Germany |
| Novartis Investigative Site | Bonn | 53119 | Germany |
| Novartis Investigative Site | Frankfurt | 60318 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Garmisch-Partenkirchen | 82467 | Germany |
| Novartis Investigative Site | Hanover | 30173 | Germany |
| Novartis Investigative Site | Kassel | 34121 | Germany |
| Novartis Investigative Site | Leipzig | 04275 | Germany |
| Novartis Investigative Site | München | 80686 | Germany |
| Novartis Investigative Site | Münster | 48147 | Germany |
| Novartis Investigative Site | Neu-Isenburg | 63263 | Germany |
| Novartis Investigative Site | Rheine | 48431 | Germany |
| Novartis Investigative Site | Siegen | 57072 | Germany |
| Novartis Investigative Site | Solingen | 42665 | Germany |
| Novartis Investigative Site | Sonneberg | 96515 | Germany |
| Novartis Investigative Site | Warendorf | 48231 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1 | QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 |
| BG001 | Treatment Sequence 2 | Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56 |
| 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 | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation | Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period | Posted | Least Squares Mean | 95% Confidence Interval | Liters | week 4 |
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| Secondary | Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire. | Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium. | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis. | Posted | Number | Participants | 8 weeks |
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| Secondary | Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions. | The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis. | Posted | Number | Participants | 8 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 | QVA149 | QVA149 | 1 | 88 | 28 | 88 | ||
| EG001 | Tiotropium | Tiotropium | 0 | 88 | 21 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | 18.1 | Systematic Assessment |
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| Cardiovascular disorder | Cardiac disorders | 18.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | 18.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | 18.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | 18.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | 18.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | 18.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | 18.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | 18.1 | Systematic Assessment |
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| Escherichia test positive | Investigations | 18.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | 18.1 | Systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
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| Hypotonia | Nervous system disorders | 18.1 | Systematic Assessment |
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| Nerve compression | Nervous system disorders | 18.1 | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | 18.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Increased viscosity of bronchial secretion | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | 18.1 | 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 |
| 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 |
|---|---|
| C554862 | indacaterol-glycopyrronium combination |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Male |
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