Trial · NCT01154127
Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01154127, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT01154127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT01154127
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- NVA237, Placebo
- First posted
- 2010-06-30
- Last updated
- 2012-05-07
- Other registries' IDs
- eudract:2010-018597-20
- Results first posted
- 2012-05-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment | Day 21 | SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Day 21 | Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Day 21 | IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest. The analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) | Day 21 | FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards. FVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period). The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Slow Vital Capacity (SVC) and Total Lung Capacity (TLC) | Day 21 | Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. Total Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period). |
| Secondary | Specific Airways Conductance (SGaw) | Day 21 | SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)\*kP). Whole body plethysmography (Bodybox) was used to measure SGaw. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment | Day 21 | The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness). A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment | Day 21 | The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness). A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
| Secondary | Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1 | Day 1 | SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting primary the PD assessment. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. n indicates number of participants with observation at each time-point. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Slow Vital Capacity (SVC) and Total Lung Capacity (TLC) | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. n indicates number of participants with observation at each time-point. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Specific Airways Conductance (SGaw) | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. | litres/(Second*kpa); kpa = kilopascal | LEAST_SQUARES_MEAN |
| SECONDARY | Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment | Day 21 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1 | Day 1 | Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. | Seconds | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment | NVA237 | 505.63 | 95% Confidence Interval 466.59 to 544.68 | seconds | |
| Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment | Placebo | 416.70 | 95% Confidence Interval 377.76 to 455.64 | seconds | |
| Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | NVA237 | 2.22 | 95% Confidence Interval 2.15 to 2.31 | Liters | |
| Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Placebo | 2.02 | 95% Confidence Interval 1.95 to 2.08 | Liters | |
| Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | NVA237 | IC at peak (Spirometry), Day 21 (n = 93, 90) | 2.22 | 95% Confidence Interval 2.16 to 2.28 | Litres |
| Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Placebo | IC at peak (Spirometry), Day 21 (n = 93, 90) | 2.03 | 95% Confidence Interval 1.97 to 2.10 | Litres |
| Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | NVA237 | IC at rest (Bodybox) Day 21 (n= 97, 96) | 2.49 | 95% Confidence Interval 2.40 to 2.59 | Litres |
| Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Placebo | IC at rest (Bodybox) Day 21 (n= 97, 96) | 2.26 | 95% Confidence Interval 2.17 to 2.35 | Litres |
| Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | NVA237 | IC at rest (Spirometry), Day 21 (n= 98, 96) | 2.39 | 95% Confidence Interval 2.33 to 2.45 | Litres |
| Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment | Placebo | IC at rest (Spirometry), Day 21 (n= 98, 96) | 2.17 | 95% Confidence Interval 2.10 to 2.23 | Litres |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (21 Days) | STARTED | NVA237 Followed by Placebo | 55 | |
| Period 1 (21 Days) | STARTED | Placebo Followed by NVA237 | 53 | |
| Period 1 (21 Days) | COMPLETED | NVA237 Followed by Placebo | 52 | |
| Period 1 (21 Days) | COMPLETED | Placebo Followed by NVA237 | 47 | |
| Period 1 (21 Days) | NOT COMPLETED | NVA237 Followed by Placebo | 3 | |
| Period 1 (21 Days) | NOT COMPLETED | Placebo Followed by NVA237 | 6 | |
| Washout (14 - 28 Days) | STARTED | NVA237 Followed by Placebo | 52 | |
| Washout (14 - 28 Days) | STARTED | Placebo Followed by NVA237 | 47 | |
| Washout (14 - 28 Days) | COMPLETED | NVA237 Followed by Placebo | 49 | |
| Washout (14 - 28 Days) | COMPLETED | Placebo Followed by NVA237 | 47 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | NVA237 | 1 | 102 | |
| serious | Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Placebo | 0 | 102 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NVA237 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | NVA237 | 0 | 102 |
| Total, other adverse events | Placebo | 0 | 102 |
| Total, serious adverse events | NVA237 | 1 | 102 |
| Total, serious adverse events | Placebo | 0 | 102 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22973092 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NVA237 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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