Trial · NCT00297102

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

NCT00297102, Phase 3, Completed, AstraZeneca; results first posted 2011-05-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124). Trials, record NCT00297102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00297102

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
NCT number: NCT00297102
Status: Completed
Phases: Phase 3
Enrollment: 1,523 participants, actual
Lead sponsor: AstraZeneca
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Roflumilast, Placebo
First posted: 2006-02-28
Last updated: 2017-01-16
Results first posted: 2011-05-19

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Change from baseline over 52 weeks of treatment	Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
Primary	COPD Exacerbation Rate (Moderate or Severe)	52 weeks treatment period	Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
Secondary	Post-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment	Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
Secondary	Time to Mortality Due to Any Reason	52 weeks treatment period
Secondary	Natural Log-transformed C-reactive Protein (CRP)	Change from baseline to last post randomization measurement (52 weeks)	Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Secondary	Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period	Change from baseline over 52 weeks of treatment	The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.

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	Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Change from baseline over 52 weeks of treatment	ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.	mL	LEAST_SQUARES_MEAN
PRIMARY	COPD Exacerbation Rate (Moderate or Severe)	52 weeks treatment period	ITT analysis.	exacerbations per patient per year	MEAN
SECONDARY	Post-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment	ITT analysis. Number of participants analyzed = number of participants with data available.	mL	LEAST_SQUARES_MEAN
SECONDARY	Time to Mortality Due to Any Reason	52 weeks treatment period	ITT analysis. Number of participants analyzed = number of participants who died.	days	MEAN
SECONDARY	Natural Log-transformed C-reactive Protein (CRP)	Change from baseline to last post randomization measurement (52 weeks)	ITT analysis. Number of participants analyzed = number of participants with data available.	mg/L	LEAST_SQUARES_MEAN
SECONDARY	Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period	Change from baseline over 52 weeks of treatment	ITT analysis. Number of participants analyzed = number of participants with data available.	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Roflumilast	46	Standard Error 8	mL
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Placebo	8	Standard Error 8	mL
COPD Exacerbation Rate (Moderate or Severe)	Roflumilast	1.077	95% Confidence Interval 0.960 to 1.207	exacerbations per patient per year
COPD Exacerbation Rate (Moderate or Severe)	Placebo	1.266	95% Confidence Interval 1.141 to 1.404	exacerbations per patient per year
Post-bronchodilator FEV1 [L]	Roflumilast	57	Standard Error 9	mL
Post-bronchodilator FEV1 [L]	Placebo	8	Standard Error 8	mL
Time to Mortality Due to Any Reason	Roflumilast	213.8	Standard Deviation 118.9	days
Time to Mortality Due to Any Reason	Placebo	207.5	Standard Deviation 108.5	days
Natural Log-transformed C-reactive Protein (CRP)	Roflumilast	1.0475	95% Confidence Interval 0.9584 to 1.1450	mg/L
Natural Log-transformed C-reactive Protein (CRP)	Placebo	1.1003	95% Confidence Interval 1.0071 to 1.2021	mg/L

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Roflumilast	765
Overall Study	STARTED	Placebo	758
Overall Study	COMPLETED	Roflumilast	502
Overall Study	COMPLETED	Placebo	525
Overall Study	NOT COMPLETED	Roflumilast	263
Overall Study	NOT COMPLETED	Placebo	233

Source ClinicalTrials.gov

Adverse events350

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	Nasopharyngitis	Infections and infestations	Roflumilast	57	769	76
other	Nasopharyngitis	Infections and infestations	Placebo	50	755	65
other	Bronchitis	Infections and infestations	Roflumilast	33	769	41
other	Bronchitis	Infections and infestations	Placebo	39	755	49
other	Diarrhoea	Gastrointestinal disorders	Roflumilast	62	769	72
other	Diarrhoea	Gastrointestinal disorders	Placebo	26	755	30
other	Nausea	Gastrointestinal disorders	Roflumilast	40	769	44
other	Nausea	Gastrointestinal disorders	Placebo	15	755	15
other	Weight decreased	Investigations	Roflumilast	92	769	94
other	Weight decreased	Investigations	Placebo	24	755	24

1 to 10 of 350Source ClinicalTrials.gov

See all 350 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Roflumilast
Total, all-cause mortality	Placebo
Total, other adverse events	Roflumilast	232	769
Total, other adverse events	Placebo	136	755
Total, serious adverse events	Roflumilast	144	769
Total, serious adverse events	Placebo	153	755

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19716960	RESULT	PubMed
20102307	DERIVED	PubMed
23117188	DERIVED	PubMed
24120253	DERIVED	PubMed
28419462	DERIVED	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
Roflumilast 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00297102

GET https://conductscience.org/api/trials/v1/NCT00297102/events?page=2

API reference For AI assistants