Trial · NCT01491802
Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD
NCT01491802, Phase 3, Completed, Queen's University; results first posted 2017-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD. Trials, record NCT01491802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01491802
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD
- NCT number
- NCT01491802
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 17 participants, actual
- Lead sponsor
- Queen's University
- Conditions
- COPD
- Interventions
- LAMA/LABA, LAMA
- First posted
- 2011-12-14
- Last updated
- 2017-08-15
- Results first posted
- 2017-08-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exertional Dyspnea Intensity at Isotime Exercise. | 4 weeks | Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests. |
| Secondary | Exercise Endurance Time | 4 weeks | Duration of constant work rate cycle exercise at 75% of maximum |
| Secondary | Inspiratory Capacity at Rest | 4 weeks | Measurements of pulmonary function included spirometry and body plethysmography. The resting inspiratory capacity (IC) values reported here are 90 minutes post-dose after 4 weeks of treatment. |
| Secondary | Ventilation at Isotime Exercise | 4 weeks | Ventilation was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests. |
| Secondary | Intensity of "Unpleasantness of Breathing" at Isotime Exercise | 4 weeks | Intensity rating (modified 10-point Borg scale) measured at a standardized time (isotime) during constant work rate exercise tests. A rating of 0 represents no "unpleasantness of breathing" up to a maximum of 10. An improvement would be noted as a decrease in the Borg scale rating. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests. |
| Secondary | Inspiratory Capacity at Isotime Exercise | 4 weeks | Measurements of inspiratory capacity (IC) were conducted during constant work rate exercise tests. Isotime was defined as the highest time in minutes completed in both post-treatment tests. |
| Secondary | Diaphragm Electromyogram (EMGdi) at Isotime Exercise | 4 weeks | EMGdi was measured during constant work rate exercise tests via a multipair-electrode esophageal catheter. EMGdi expressed as a percentage of its maximum is used as an index of inspiratory neural drive. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests. |
| Secondary | Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise | 4 weeks | Tidal esophageal pressure (Pes) swings were measured via an esophageal balloon catheter during constant work rate exercise tests. Tidal Pes expressed relative to maximum is an index of respiratory effort. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests. |
| Secondary | Mean Expiratory Flow at Isotime Exercise | 4 weeks | Mean expiratory flow was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) | 4 weeks | Measurements of pulmonary function included spirometry and body plethysmography. Values reported are 90 minutes post-dose after 4 weeks of treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Exertional Dyspnea Intensity at Isotime Exercise. | 4 weeks | Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis. | units on a scale | MEAN |
| SECONDARY | Exercise Endurance Time | 4 weeks | minutes | MEAN | |
| SECONDARY | Inspiratory Capacity at Rest | 4 weeks | 14 subjects completed both treatments for comparison. | L | MEAN |
| SECONDARY | Ventilation at Isotime Exercise | 4 weeks | 14 subjects completed both treatment arms for comparison. | L/min | MEAN |
| SECONDARY | Intensity of Unpleasantness of Breathing at Isotime Exercise | 4 weeks | Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis. | units on a scale | MEAN |
| SECONDARY | Inspiratory Capacity at Isotime Exercise | 4 weeks | 14 subjects completed both treatment arms for comparison. | L | MEAN |
| SECONDARY | Diaphragm Electromyogram (EMGdi) at Isotime Exercise | 4 weeks | Although 14 subjects completed both treatment arms, only 9 subjects had complete measurements of EMGdi and respiratory pressures. | percentage of maximum EMGdi | MEAN |
| SECONDARY | Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise | 4 weeks | Although 14 subjects completed both treatment arms for comparison, only 9 subjects also had complete measurements of EMGdi and respiratory pressures. | percentage of maximum Pes | MEAN |
| SECONDARY | Mean Expiratory Flow at Isotime Exercise | 4 weeks | 14 subjects completed both treatment arms for comparison. | L/s | MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second (FEV1) | 4 weeks | 14 subjects completed both treatments for comparison. | L | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Exertional Dyspnea Intensity at Isotime Exercise. | LAMA | 3.9 | Standard Deviation 2.4 | units on a scale | |
| Exertional Dyspnea Intensity at Isotime Exercise. | LABA/LAMA Combination | 3.4 | Standard Deviation 2.3 | units on a scale | |
| Exercise Endurance Time | LAMA | 7.82 | Standard Deviation 6.15 | minutes | |
| Exercise Endurance Time | LABA/LAMA Combination | 7.49 | Standard Deviation 4.99 | minutes | |
| Inspiratory Capacity at Rest | LAMA | 2.27 | Standard Deviation 0.40 | L | |
| Inspiratory Capacity at Rest | LABA/LAMA Combination | 2.36 | Standard Deviation 0.86 | L | |
| Ventilation at Isotime Exercise | LAMA | 44.9 | Standard Deviation 16.3 | L/min | |
| Ventilation at Isotime Exercise | LABA/LAMA Combination | 47.5 | Standard Deviation 18.4 | L/min | |
| Intensity of Unpleasantness of Breathing at Isotime Exercise | LAMA | 4.0 | Standard Deviation 2.5 | units on a scale | |
| Intensity of Unpleasantness of Breathing at Isotime Exercise | LABA/LAMA Combination | 3.3 | Standard Deviation 2.3 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LAMA, Then LAMA/LABA | 9 | |
| Overall Study | STARTED | LAMA/LABA, the LAMA | 8 | |
| Overall Study | COMPLETED | LAMA, Then LAMA/LABA | 8 | |
| Overall Study | COMPLETED | LAMA/LABA, the LAMA | 6 | |
| Overall Study | NOT COMPLETED | LAMA, Then LAMA/LABA | 1 | |
| Overall Study | NOT COMPLETED | LAMA/LABA, the LAMA | 2 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| other | COPD exacerbation | Respiratory, thoracic and mediastinal disorders | LAMA Arm | 0 | 17 | 0 |
| other | COPD exacerbation | Respiratory, thoracic and mediastinal disorders | LABA/LAMA Arm | 0 | 17 | 0 |
| other | COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Washout Period | 1 | 17 | 1 |
| other | Pancreatitis | Endocrine disorders | LAMA Arm | 1 | 17 | 1 |
| other | Pancreatitis | Endocrine disorders | LABA/LAMA Arm | 0 | 17 | 0 |
| other | Pancreatitis | Endocrine disorders | Washout Period | 0 | 17 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LAMA Arm | ||
| Total, all-cause mortality | LABA/LAMA Arm | ||
| Total, all-cause mortality | Washout Period | ||
| Total, other adverse events | LAMA Arm | 1 | 17 |
| Total, other adverse events | LABA/LAMA Arm | 0 | 17 |
| Total, other adverse events | Washout Period | 1 | 17 |
| Total, serious adverse events | LAMA Arm | 0 | 17 |
| Total, serious adverse events | LABA/LAMA Arm | 0 | 17 |
| Total, serious adverse events | Washout Period | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01491802
GET https://conductscience.org/api/trials/v1/NCT01491802/registered