Trial · NCT01443845

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

NCT01443845, Phase 4, Completed, AstraZeneca; results first posted 2017-01-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS). Trials, record NCT01443845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01443845

On this page

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 Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
NCT number: NCT01443845
Status: Completed
Phases: Phase 4
Enrollment: 2,354 participants, actual
Lead sponsor: AstraZeneca
Conditions: COPD, COPD Exacerbation, Lung Diseases, Respiratory Disorders, Pulmonary Disease, Chronic Obstructive Lung Diseases, Chronic Obstructive Airway Disease
Interventions: Roflumilast, Placebo
First posted: 2011-09-30
Last updated: 2017-04-13
Results first posted: 2017-01-25

Source ClinicalTrials.gov

Registered outcomes4

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.	Baseline to Week 52	Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
Secondary	Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)	Week 0 (Visit 2) to Week 52	Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
Secondary	Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics	Week 0 (Visit 2) to Week 52	Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.
Secondary	Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)	Week 0 (Visit 2) to Week 52	Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)

Source ClinicalTrials.gov

Outcomes4

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.	Baseline to Week 52	Intent-to-Treat Study Population	COPD exacerbations per patient per year	NUMBER
SECONDARY	Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)	Week 0 (Visit 2) to Week 52	Intent-to-Treat Study Population	COPD exacerbations per patient per year	NUMBER
SECONDARY	Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics	Week 0 (Visit 2) to Week 52		COPD Exacerbations per Patient per Year	NUMBER
SECONDARY	Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)	Week 0 (Visit 2) to Week 52	Intent-to-Treat Population who the completed 52-week treatment period	Liters	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.	Placebo	1.27	95% Confidence Interval 1.17 to 1.39	COPD exacerbations per patient per year
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.	Roflumilast	1.17	95% Confidence Interval 1.06 to 1.28	COPD exacerbations per patient per year
Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)	Placebo	0.29	95% Confidence Interval 0.25 to 0.34	COPD exacerbations per patient per year
Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)	Roflumilast	0.28	95% Confidence Interval 0.23 to 0.33	COPD exacerbations per patient per year
Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics	Placebo	1.45	95% Confidence Interval 1.34 to 1.57	COPD Exacerbations per Patient per Year
Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics	Roflumilast	1.31	95% Confidence Interval 1.20 to 1.43	COPD Exacerbations per Patient per Year
Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)	Placebo	-0.0091	Standard Error 0.0047	Liters
Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)	Roflumilast	0.0441	Standard Error 0.0048	Liters

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	1,176
Overall Study	STARTED	Roflumilast	1,178
Overall Study	COMPLETED	Placebo	922
Overall Study	COMPLETED	Roflumilast	841
Overall Study	NOT COMPLETED	Placebo	254
Overall Study	NOT COMPLETED	Roflumilast	337

Source ClinicalTrials.gov

Adverse events686

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
other	Weight decreased	Investigations	Placebo	27	1,174
other	Weight decreased	Investigations	Roflumilast	91	1,178
other	Headache	Nervous system disorders	Placebo	48	1,174
other	Headache	Nervous system disorders	Roflumilast	80	1,178
other	Diarrhoea	Gastrointestinal disorders	Placebo	36	1,174
other	Diarrhoea	Gastrointestinal disorders	Roflumilast	119	1,178
other	Nausea	Gastrointestinal disorders	Placebo	30	1,174
other	Nausea	Gastrointestinal disorders	Roflumilast	62	1,178
other	Upper respiratory tract infection	Infections and infestations	Placebo	66	1,174
other	Upper respiratory tract infection	Infections and infestations	Roflumilast	60	1,178

1 to 10 of 686Source ClinicalTrials.gov

See all 686 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Roflumilast
Total, other adverse events	Placebo	188	1,174
Total, other adverse events	Roflumilast	317	1,178
Total, serious adverse events	Placebo	162	1,174
Total, serious adverse events	Roflumilast	180	1,178

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27585384	DERIVED	PubMed
29579254	DERIVED	PubMed
29763572	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/NCT01443845

GET https://conductscience.org/api/trials/v1/NCT01443845/events?page=2

API reference For AI assistants