Trial · NCT00900731
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
NCT00900731, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT00900731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00900731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT00900731
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,598 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Indacaterol 150 μg, Tiotropium 18 μg, Placebo to indacaterol, Placebo to tiotropium
- First posted
- 2009-05-13
- Last updated
- 2011-08-19
- Results first posted
- 2011-08-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) | End of treatment (Week 12) | Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12) | 5 minutes to 4 hours post-dose at the end of treatment (week 12) | Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment | 12 weeks | TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment | 12 weeks | SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning \& psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Baseline, up to 12 weeks | Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Baseline, up to 12 weeks | Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Baseline, up to 12 weeks | Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
| Secondary | Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment | Up to 12 weeks | A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) | End of treatment (Week 12) | Per-protocol population included all participants who received at least one dose of study medication without any major protocol deviations. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data were imputed using last observation carried forward. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12) | 5 minutes to 4 hours post-dose at the end of treatment (week 12) | Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. | Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment | 12 weeks | Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment | 12 weeks | Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Baseline, up to 12 weeks | Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure. | Puffs | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Baseline, up to 12 weeks | Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure. | Puffs | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Baseline, up to 12 weeks | Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure. | Puffs | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment | Up to 12 weeks | Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure. | Percentage of days | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) | Indacaterol 150 µg | 1.44 | Standard Error 0.010 | Liters | |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) | Tiotropium 18 µg | 1.43 | Standard Error 0.010 | Liters | |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12) | Indacaterol 150 µg | 1.51 | Standard Error 0.010 | Liter | |
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12) | Tiotropium 18 µg | 1.52 | Standard Error 0.010 | Liter | |
| Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment | Indacaterol 150 µg | 2.01 | Standard Error 0.178 | Score on a scale | |
| Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment | Tiotropium 18 µg | 1.43 | Standard Error 0.178 | Score on a scale | |
| Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment | Indacaterol 150 µg | 37.1 | Standard Error 0.56 | Score on a scale | |
| Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment | Tiotropium 18 µg | 39.2 | Standard Error 0.55 | Score on a scale | |
| Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Indacaterol 150 µg | -1.40 | Standard Error 0.097 | Puffs | |
| Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12) | Tiotropium 18 µg | -0.85 | Standard Error 0.097 | Puffs |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indacaterol 150 µg | 797 | |
| Overall Study | STARTED | Tiotropium 18 µg | 801 | |
| Overall Study | Safety Set: Received Study Drug | Indacaterol 150 µg | 794 | |
| Overall Study | Safety Set: Received Study Drug | Tiotropium 18 µg | 799 | |
| Overall Study | COMPLETED | Indacaterol 150 µg | 737 | |
| Overall Study | COMPLETED | Tiotropium 18 µg | 740 | |
| Overall Study | NOT COMPLETED | Indacaterol 150 µg | 60 | |
| Overall Study | NOT COMPLETED | Tiotropium 18 µg | 61 |
Source ClinicalTrials.gov
Adverse events134
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 | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Indacaterol 150 μg | 80 | 794 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Tiotropium 18 μg | 61 | 799 | |
| serious | Acute coronary syndrome | Cardiac disorders | Indacaterol 150 μg | 1 | 794 | |
| serious | Acute coronary syndrome | Cardiac disorders | Tiotropium 18 μg | 0 | 799 | |
| serious | Angina pectoris | Cardiac disorders | Indacaterol 150 μg | 1 | 794 | |
| serious | Angina pectoris | Cardiac disorders | Tiotropium 18 μg | 0 | 799 | |
| serious | Arrhythmia | Cardiac disorders | Indacaterol 150 μg | 0 | 794 | |
| serious | Arrhythmia | Cardiac disorders | Tiotropium 18 μg | 2 | 799 | |
| serious | Atrial fibrillation | Cardiac disorders | Indacaterol 150 μg | 0 | 794 | |
| serious | Atrial fibrillation | Cardiac disorders | Tiotropium 18 μg | 1 | 799 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Indacaterol 150 μg | ||
| Total, all-cause mortality | Tiotropium 18 μg | ||
| Total, other adverse events | Indacaterol 150 μg | 80 | 794 |
| Total, other adverse events | Tiotropium 18 μg | 61 | 799 |
| Total, serious adverse events | Indacaterol 150 μg | 22 | 794 |
| Total, serious adverse events | Tiotropium 18 μg | 30 | 799 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21622587 | 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 |
|---|
| Indacaterol 150 μg vs Tiotropium 18 μg: 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.
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/NCT00900731
GET https://conductscience.org/api/trials/v1/NCT00900731/events?page=2