Trial · NCT01329029
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
NCT01329029, Phase 4, Completed, AstraZeneca; results first posted 2015-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS). Trials, record NCT01329029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01329029
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
- NCT number
- NCT01329029
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,945 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Roflumilast, Placebo
- First posted
- 2011-04-05
- Last updated
- 2016-12-13
- Other registries' IDs
- eudract:2010-019685-87
- Results first posted
- 2015-10-29
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | 52 weeks | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. |
| Secondary | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Baseline and Week 52 | Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement. |
| Secondary | Rate of Severe COPD Exacerbations Per Patient Per Year | 52 weeks | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. |
| Secondary | Rate of COPD Exacerbations Per Patient Per Year All Categories | 52 weeks | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year. |
| Secondary | Percentage of Participants Experiencing at Least 1 COPD Exacerbation | 52 weeks | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. |
| Secondary | Time to First COPD Exacerbation All Categories | 52 Weeks | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. |
| Secondary | Time to Second Moderate or Severe COPD Exacerbation | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. |
| Secondary | Time to Third Moderate or Severe COPD Exacerbation | 52 Weeks | Time to event was calculated as date of onset of event - date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. |
| Secondary | Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year | 52 Weeks | The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)- Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy. |
| Secondary | Number of Moderate or Severe COPD Exacerbation Days | 52 Weeks | A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation - start date of exacerbation + 1) of all exacerbations within the category. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | exacerbations per patient per year | MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Baseline and Week 52 | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Severe COPD Exacerbations Per Patient Per Year | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | exacerbations per patient per year | MEAN |
| SECONDARY | Rate of COPD Exacerbations Per Patient Per Year All Categories | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | exacerbations per patient per year | MEAN |
| SECONDARY | Percentage of Participants Experiencing at Least 1 COPD Exacerbation | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Time to First COPD Exacerbation All Categories | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | days | MEDIAN |
| SECONDARY | Time to Second Moderate or Severe COPD Exacerbation | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | days | MEDIAN |
| SECONDARY | Time to Third Moderate or Severe COPD Exacerbation | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | days | MEDIAN |
| SECONDARY | Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | participants | NUMBER |
| SECONDARY | Number of Moderate or Severe COPD Exacerbation Days | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | days | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | Roflumilast 500 µg | 0.805 | 95% Confidence Interval 0.724 to 0.895 | exacerbations per patient per year | |
| Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | Placebo | 0.927 | 95% Confidence Interval 0.843 to 1.020 | exacerbations per patient per year | |
| Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Roflumilast 500 µg | 0.052 | Standard Error 0.0064 | liters | |
| Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Placebo | -0.004 | Standard Error 0.0062 | liters | |
| Rate of Severe COPD Exacerbations Per Patient Per Year | Roflumilast 500 µg | 0.239 | 95% Confidence Interval 0.201 to 0.283 | exacerbations per patient per year | |
| Rate of Severe COPD Exacerbations Per Patient Per Year | Placebo | 0.315 | 95% Confidence Interval 0.270 to 0.368 | exacerbations per patient per year | |
| Rate of COPD Exacerbations Per Patient Per Year All Categories | Roflumilast 500 µg | Moderate | 0.574 | 95% Confidence Interval 0.508 to 0.648 | exacerbations per patient per year |
| Rate of COPD Exacerbations Per Patient Per Year All Categories | Placebo | Moderate | 0.627 | 95% Confidence Interval 0.561 to 0.702 | exacerbations per patient per year |
| Rate of COPD Exacerbations Per Patient Per Year All Categories | Roflumilast 500 µg | Mild, Moderate or Severe | 3.078 | 95% Confidence Interval 2.723 to 3.479 | exacerbations per patient per year |
| Rate of COPD Exacerbations Per Patient Per Year All Categories | Placebo | Mild, Moderate or Severe | 3.879 | 95% Confidence Interval 3.492 to 4.310 | exacerbations per patient per year |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roflumilast 500 µg | 973 | |
| Overall Study | STARTED | Placebo | 972 | |
| Overall Study | Full Analysis Set (FAS) | Roflumilast 500 µg | 969 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 966 | |
| Overall Study | Safety Population | Roflumilast 500 µg | 968 | |
| Overall Study | Safety Population | Placebo | 967 | |
| Overall Study | COMPLETED | Roflumilast 500 µg | 704 | |
| Overall Study | COMPLETED | Placebo | 780 | |
| Overall Study | NOT COMPLETED | Roflumilast 500 µg | 269 | |
| Overall Study | NOT COMPLETED | Placebo | 192 |
Source ClinicalTrials.gov
Adverse events458
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 | Roflumilast 500 µg | 97 | 968 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 33 | 967 | |
| other | Nausea | Gastrointestinal disorders | Roflumilast 500 µg | 55 | 968 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 15 | 967 | |
| other | Nasopharyngitis | Infections and infestations | Roflumilast 500 µg | 52 | 968 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 52 | 967 | |
| other | Weight decreased | Investigations | Roflumilast 500 µg | 84 | 968 | |
| other | Weight decreased | Investigations | Placebo | 27 | 967 | |
| serious | Anaemia | Blood and lymphatic system disorders | Roflumilast 500 µg | 2 | 968 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 967 |
1 to 10 of 458Source ClinicalTrials.gov
See all 458 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roflumilast 500 µg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Roflumilast 500 µg | 228 | 968 |
| Total, other adverse events | Placebo | 114 | 967 |
| Total, serious adverse events | Roflumilast 500 µg | 249 | 968 |
| Total, serious adverse events | Placebo | 285 | 967 |
Source ClinicalTrials.gov
Papers5
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 |
|---|
| Roflumilast 500 µg vs Placebo: 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/NCT01329029
GET https://conductscience.org/api/trials/v1/NCT01329029/registered?page=2