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This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence I | Active Comparator | QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days |
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| Treatment sequence II | Active Comparator | Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 (110/50 µg) once a day via Breezhaler® device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo | Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Baseline, day 22, baseline day 36, day 57 |
| Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level | Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Baseline, day 22, baseline day 36, day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day | The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day 1 or Day 57-Day36 |
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Inclusion Criteria:
Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70
Exclusion Criteria:
Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.
Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.
Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
Patients who have had a respiratory tract infection within 4 weeks prior to screening.
Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Heidelberg | Germany | 69117 | Germany | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27301417 | Derived | Watz H, Mailander C, Baier M, Kirsten A. Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled, crossover study (The MOVE Study). BMC Pulm Med. 2016 Jun 14;16(1):95. doi: 10.1186/s12890-016-0256-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 Then Placebo | QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days |
| FG001 | Placebo Then QVA149 | Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo once a day via Breezhaler® device |
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| Baseline, day 22, baseline day 36, day 57 |
| Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo | Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Baseline, day 22, baseline day 36, day 57 |
| Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1. | Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days | Day 1 or day 36 |
| Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo | Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Baseline, day 22, baseline day 36, day 57 |
| Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days | Day 1 or day 36 |
| Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Baseline, day 22, baseline day 36, day 57 |
| Potsdam |
| Germany |
| 14467 |
| Germany |
| Novartis Investigative Site | Teterow | Germany | 17166 | Germany |
| Novartis Investigative Site | Koblenz | North Rhine-Westphalia | 56068 | Germany |
| Novartis Investigative Site | Cottbus | Saxony | 03050 | Germany |
| Novartis Investigative Site | Geesthacht | Schleswig-Holstein | 12502 | Germany |
| Novartis Investigative Site | Berlin | State of Berlin | 10119 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Berlin | 10629 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Cologne | 51605 | Germany |
| Novartis Investigative Site | Düren | 52349 | Germany |
| Novartis Investigative Site | Erlangen | 91052 | Germany |
| Novartis Investigative Site | Euskirchen | 53879 | Germany |
| Novartis Investigative Site | Großhansdorf | 22947 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Höchstadt an der Aisch | 91315 | Germany |
| Novartis Investigative Site | Kassel | 34121 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Leipzig | 04207 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Lübeck | 23558 | Germany |
| Novartis Investigative Site | Marburg | 35037 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Neunkirchen | 66539 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Rheine | 48431 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Saarbrücken | 66111 | Germany |
| Novartis Investigative Site | Wiesloch | 69168 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 Then Placebo | QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days |
| BG001 | Placebo Then QVA149 | Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days |
| 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 |
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| 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 | Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo | Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Baseline, day 22, baseline day 36, day 57 |
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| Primary | Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level | Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | kcal/day | Baseline, day 22, baseline day 36, day 57 |
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| Secondary | Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day | The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day 1 or Day 57-Day36 | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis | Posted | Mean | Standard Deviation | Steps/day | Baseline, day 22, baseline day 36, day 57 |
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| Secondary | Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo | Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22, plus baseline day 36 and day 57 data were included in this analysis. | Posted | Mean | Standard Deviation | Minutes | Baseline, day 22, baseline day 36, day 57 |
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| Secondary | Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1. | Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 1 post treatment initiation were included in this analysis. | Posted | Mean | Standard Deviation | Liters | Day 1 or day 36 |
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| Secondary | Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo | Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis. | Posted | Mean | Standard Deviation | Liters | Baseline, day 22, baseline day 36, day 57 |
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| Secondary | Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period | Posted | Mean | Standard Deviation | Liters | Day 1 or day 36 |
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| Secondary | Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36 | Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period | Posted | Mean | Standard Deviation | Liters | Baseline, day 22, baseline day 36, day 57 |
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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 Then Placebo | QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days | 4 | 193 | 27 | 193 | ||
| EG001 | Placebo Then QVA149 | Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days | 2 | 188 | 19 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | 18.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | 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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| Back pain | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
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| Cough | 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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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Sputum increased | Respiratory, thoracic and mediastinal 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 |
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