Trial · NCT00845728
Exacerbation Study
NCT00845728, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exacerbation Study. Trials, record NCT00845728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00845728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exacerbation Study
- NCT number
- NCT00845728
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,439 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Indacaterol 150 µg, Tiotropium
- First posted
- 2009-02-18
- Last updated
- 2013-11-19
- Results first posted
- 2013-11-19
Source ClinicalTrials.gov
Registered outcomes2
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). | 12 weeks | The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model. |
| Secondary | Rate of COPD Exacerbations | 52 weeks | COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model. |
Source ClinicalTrials.gov
Outcomes2
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). | 12 weeks | Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of COPD Exacerbations | 52 weeks | Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy. | Exacerbations per patient per year | NUMBER |
Source ClinicalTrials.gov
Results by group4
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). | Indacaterol | 1.134 | Standard Error 0.0008 | Liters | |
| Trough Forced Expiratory Volume in 1 Second (FEV1). | Tiotropium | 1.145 | Standard Error 0.0008 | Liters | |
| Rate of COPD Exacerbations | Indacaterol | 0.79 | Exacerbations per patient per year | ||
| Rate of COPD Exacerbations | Tiotropium | 0.61 | Exacerbations per patient per year |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indacaterol | 1,723 | |
| Overall Study | STARTED | Tiotropium | 1,721 | |
| Overall Study | Exposed | Indacaterol | 1,721 | |
| Overall Study | Exposed | Tiotropium | 1,718 | |
| Overall Study | COMPLETED | Indacaterol | 1,337 | |
| Overall Study | COMPLETED | Tiotropium | 1,379 | |
| Overall Study | NOT COMPLETED | Indacaterol | 386 | |
| Overall Study | NOT COMPLETED | Tiotropium | 342 |
Source ClinicalTrials.gov
Adverse events610
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 | Diarrhoea | Gastrointestinal disorders | IndIndacaterol | 26 | 1,721 | |
| other | Diarrhoea | Gastrointestinal disorders | Tiotropium | 43 | 1,718 | |
| other | Bronchitis | Infections and infestations | IndIndacaterol | 39 | 1,721 | |
| other | Bronchitis | Infections and infestations | Tiotropium | 34 | 1,718 | |
| other | Influenza | Infections and infestations | IndIndacaterol | 38 | 1,721 | |
| other | Influenza | Infections and infestations | Tiotropium | 45 | 1,718 | |
| other | Lower respiratory tract infection | Infections and infestations | IndIndacaterol | 125 | 1,721 | |
| other | Lower respiratory tract infection | Infections and infestations | Tiotropium | 98 | 1,718 | |
| other | Nasopharyngitis | Infections and infestations | IndIndacaterol | 118 | 1,721 | |
| other | Nasopharyngitis | Infections and infestations | Tiotropium | 101 | 1,718 |
1 to 10 of 610Source ClinicalTrials.gov
See all 610 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IndIndacaterol | ||
| Total, all-cause mortality | Tiotropium | ||
| Total, other adverse events | IndIndacaterol | 890 | 1,721 |
| Total, other adverse events | Tiotropium | 793 | 1,718 |
| Total, serious adverse events | IndIndacaterol | 263 | 1,721 |
| Total, serious adverse events | Tiotropium | 255 | 1,718 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24461613 | 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 |
|---|
| IndIndacaterol vs Tiotropium: 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/NCT00845728
GET https://conductscience.org/api/trials/v1/NCT00845728/events?page=2