Trial · NCT01490125
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01490125, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT01490125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01490125
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT01490125
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 247 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- QVA149, Tiotropium, Placebo to QVA149, Placebo to tiotropium, Salbutamol/albuterol
- First posted
- 2011-12-12
- Last updated
- 2013-12-24
- Other registries' IDs
- eudract:2011-000229-63
- Results first posted
- 2013-12-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo | Baseline and 6 weeks | Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period. |
| Secondary | Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium | Baseline and 6 weeks | Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period. |
| Secondary | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium | 5min-4hr at day 1 and week 6 post-dose | Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time. |
| Secondary | Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium | 5min-4hr at day 1 and week 6 post-dose | Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6. |
| Secondary | Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment | Baseline and 6 weeks | The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from "not at all difficult" to "extremely difficult". For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference. |
| Secondary | Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment | Baseline and 6 weeks | The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo | Baseline and 6 weeks | The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients. | Units on a scale | MEAN |
| SECONDARY | Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium | Baseline and 6 weeks | The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients. | Units on a scale | MEAN |
| SECONDARY | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium | 5min-4hr at day 1 and week 6 post-dose | The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium | 5min-4hr at day 1 and week 6 post-dose | The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment | Baseline and 6 weeks | The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment | Baseline and 6 weeks | The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients. | puffs | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo | QVA149 + Placebo to Tiotropium | BDI | 7.34 | Standard Deviation 2.033 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo | Placebo | BDI | 7.33 | Standard Deviation 2.206 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo | QVA149 + Placebo to Tiotropium | TDI | 0.98 | Standard Deviation 2.666 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo | Placebo | TDI | -0.38 | Standard Deviation 2.308 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium | QVA149 + Placebo to Tiotropium | BDI | 7.34 | Standard Deviation 2.033 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium | Tiotropium + Placebo to QVA149 | BDI | 7.31 | Standard Deviation 2.199 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium | QVA149 + Placebo to Tiotropium | TDI | 0.98 | Standard Deviation 2.666 | Units on a scale |
| Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium | Tiotropium + Placebo to QVA149 | TDI | 0.47 | Standard Deviation 2.184 | Units on a scale |
| Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium | QVA149 + Placebo to Tiotropium | Day 1 (n=220,219,2117) | 1.564 | Standard Error 0.0082 | Liters |
| Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium | Tiotropium + Placebo to QVA149 | Day 1 (n=220,219,2117) | 1.496 | Standard Error 0.0082 | Liters |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I | STARTED | QVA149+ Placebo+ Tiotropium | 43 | |
| Period I | STARTED | QVA149+ Tiotropium+ Placebo | 42 | |
| Period I | STARTED | Placebo + QVA149 + Tiotropium | 41 | |
| Period I | STARTED | Placebo+ Tiotropium + QVA149 | 38 | |
| Period I | STARTED | Tiotropium + QVA149+ Placebo | 40 | |
| Period I | STARTED | Tiotropium + Placebo +QVA149 | 42 | |
| Period I | COMPLETED | QVA149+ Placebo+ Tiotropium | 37 | |
| Period I | COMPLETED | QVA149+ Tiotropium+ Placebo | 37 | |
| Period I | COMPLETED | Placebo + QVA149 + Tiotropium | 37 | |
| Period I | COMPLETED | Placebo+ Tiotropium + QVA149 | 33 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events153
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 | Anaemia | Blood and lymphatic system disorders | QVA149 + Placebo to Tiotropium | 0 | 223 | |
| other | Anaemia | Blood and lymphatic system disorders | Tiotropium + Placebo to QVA149 | 2 | 220 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 218 | |
| other | Constipation | Gastrointestinal disorders | QVA149 + Placebo to Tiotropium | 2 | 223 | |
| other | Constipation | Gastrointestinal disorders | Tiotropium + Placebo to QVA149 | 0 | 220 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 218 | |
| other | Diarrhoea | Gastrointestinal disorders | QVA149 + Placebo to Tiotropium | 2 | 223 | |
| other | Diarrhoea | Gastrointestinal disorders | Tiotropium + Placebo to QVA149 | 1 | 220 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 218 | |
| other | Dry mouth | Gastrointestinal disorders | QVA149 + Placebo to Tiotropium | 1 | 223 |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QVA149 + Placebo to Tiotropium | ||
| Total, all-cause mortality | Tiotropium + Placebo to QVA149 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | QVA149 + Placebo to Tiotropium | 51 | 223 |
| Total, other adverse events | Tiotropium + Placebo to QVA149 | 58 | 220 |
| Total, other adverse events | Placebo | 70 | 218 |
| Total, serious adverse events | QVA149 + Placebo to Tiotropium | 6 | 223 |
| Total, serious adverse events | Tiotropium + Placebo to QVA149 | 6 | 220 |
| Total, serious adverse events | Placebo | 5 | 218 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24176997 | 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 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/NCT01490125
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