Trial · NCT01782326
QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)
NCT01782326, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations). Trials, record NCT01782326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01782326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)
- NCT number
- NCT01782326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,362 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- QVA149, Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
- First posted
- 2013-02-01
- Last updated
- 2016-05-16
- Results first posted
- 2016-05-16
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of COPD Exacerbations | 52 weeks | COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used. |
| Secondary | Time to First COPD Exacerbation. | 52 weeks | First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. |
| Secondary | Rate of Moderate to Severe COPD Exacerbations. | 52 weeks | COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. |
| Secondary | Time to First Moderate to Severe COPD Exacerbation. | 52 weeks. | First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. |
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | 52 weeks | COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. |
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | 52 weeks | Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included . |
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included. | 52 weeks | All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization. |
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | 52 weeks | Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included. |
| Secondary | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | 52 weeks | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. |
| Secondary | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | 52 weeks | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of COPD Exacerbations | 52 weeks | The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbations/year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First COPD Exacerbation. | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations. | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbation. | 52 weeks. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included. | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | MEAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of COPD Exacerbations | QVA149 | 3.59 | 95% Confidence Interval 3.28 to 3.94 | COPD Exacerbations/year | |
| Rate of COPD Exacerbations | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 4.03 | 95% Confidence Interval 3.68 to 4.41 | COPD Exacerbations/year | |
| Time to First COPD Exacerbation. | QVA149 | 71.0 | 95% Confidence Interval 60.0 to 82.0 | Days | |
| Time to First COPD Exacerbation. | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 51.0 | 95% Confidence Interval 46.0 to 57.0 | Days | |
| Rate of Moderate to Severe COPD Exacerbations. | QVA149 | 0.98 | 95% Confidence Interval 0.88 to 1.10 | COPD Exacerbation/year | |
| Rate of Moderate to Severe COPD Exacerbations. | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 1.19 | 95% Confidence Interval 1.07 to 1.32 | COPD Exacerbation/year | |
| Time to First Moderate to Severe COPD Exacerbation. | QVA149 | NA | 95% Confidence Interval NA to NA | Days | |
| Time to First Moderate to Severe COPD Exacerbation. | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 308.0 | 95% Confidence Interval 283.0 to 352.0 | Days | |
| Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | QVA149 | 0.18 | 95% Confidence Interval 0.14 to 0.22 | COPD Exacerbation/year | |
| Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 0.18 | 95% Confidence Interval 0.14 to 0.23 | COPD Exacerbation/year |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Planned Treatment Epoch | STARTED | QVA149 | 1,680 | |
| Planned Treatment Epoch | STARTED | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 1,682 | |
| Planned Treatment Epoch | Full Analysis Set (FAS) | QVA149 | 1,675 | |
| Planned Treatment Epoch | Full Analysis Set (FAS) | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 1,679 | |
| Planned Treatment Epoch | Per-protocol Set (PPS) | QVA149 | 1,528 | |
| Planned Treatment Epoch | Per-protocol Set (PPS) | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 1,556 | |
| Planned Treatment Epoch | Serial Spirometry Set | QVA149 | 280 | |
| Planned Treatment Epoch | Serial Spirometry Set | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 279 | |
| Planned Treatment Epoch | Safety Set (SAF) | QVA149 | 1,678 | |
| Planned Treatment Epoch | Safety Set (SAF) | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 1,680 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events702
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 | CONSTIPATION | Gastrointestinal disorders | QVA149 | 19 | 1,678 | |
| other | CONSTIPATION | Gastrointestinal disorders | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 17 | 1,680 | |
| other | DIARRHOEA | Gastrointestinal disorders | QVA149 | 19 | 1,678 | |
| other | DIARRHOEA | Gastrointestinal disorders | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 24 | 1,680 | |
| other | DYSPEPSIA | Gastrointestinal disorders | QVA149 | 18 | 1,678 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 9 | 1,680 | |
| other | GASTRITIS | Gastrointestinal disorders | QVA149 | 10 | 1,678 | |
| other | GASTRITIS | Gastrointestinal disorders | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 20 | 1,680 | |
| other | NON-CARDIAC CHEST PAIN | General disorders | QVA149 | 20 | 1,678 | |
| other | NON-CARDIAC CHEST PAIN | General disorders | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 11 | 1,680 |
1 to 10 of 702Source ClinicalTrials.gov
See all 702 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QVA149 | ||
| Total, all-cause mortality | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | ||
| Total, other adverse events | QVA149 | 1,363 | 1,678 |
| Total, other adverse events | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 1,424 | 1,680 |
| Total, serious adverse events | QVA149 | 308 | 1,678 |
| Total, serious adverse events | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | 334 | 1,680 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| QVA149 vs Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS): 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.
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GET https://conductscience.org/api/trials/v1/NCT01782326/registered?page=2