Trial · NCT01572948

A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

NCT01572948, Not applicable, Completed, University of Alabama at Birmingham; results first posted 2015-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT01572948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01572948

On this page

Trial

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

Title: A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)
NCT number: NCT01572948
Status: Completed
Phases: Not applicable
Enrollment: 27 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: COPD
Interventions: roflumilast, placebo
First posted: 2012-04-06
Last updated: 2015-10-19
Results first posted: 2015-07-31
Limitations and caveats: small sample size and limited follow-up

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame
Primary	Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline	baseline
Primary	Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.	1 month after baseline
Primary	Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization	3 months after baseline
Secondary	Induced Sputum Neutrophil Count	1 month
Secondary	Induced Sputum Neutrophil Count	baseline
Secondary	Induced Sputum Neutrophil Count	3 months after baseline

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline	baseline	ng/ml	MEAN
SECONDARY	Induced Sputum Neutrophil Count	1 month	percentage of sputum neutrophils	MEAN
PRIMARY	Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.	1 month after baseline	ng/ml	MEAN
PRIMARY	Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization	3 months after baseline	ng/ml	MEAN
SECONDARY	Induced Sputum Neutrophil Count	baseline	percentage of sputum neutrophils	MEAN
SECONDARY	Induced Sputum Neutrophil Count	3 months after baseline	percentage of sputum neutrophils	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
Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline	Placebo	0.74	Standard Deviation 0.25	ng/ml
Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline	Roflumilast	0.64	Standard Deviation 0.21	ng/ml
Induced Sputum Neutrophil Count	Placebo	83	Standard Error .24	percentage of sputum neutrophils
Induced Sputum Neutrophil Count	Daliresp	80	Standard Error .24	percentage of sputum neutrophils
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.	Roflumilast	.33	Standard Deviation .12	ng/ml
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.	Placebo	.66	Standard Deviation .18	ng/ml
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization	Placebo	0.70	Standard Deviation 0.18	ng/ml
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization	Roflumilast	0.30	Standard Deviation 0.11	ng/ml
Induced Sputum Neutrophil Count	Placebo	89	Standard Error .25	percentage of sputum neutrophils
Induced Sputum Neutrophil Count	Roflumilast	83	Standard Error .23	percentage of sputum neutrophils

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	11
Overall Study	STARTED	Placebo	16
Overall Study	COMPLETED	Roflumilast	10
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Roflumilast	1
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events16

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	Nausea	Gastrointestinal disorders	Placebo	0	16	0
other	Nausea	Gastrointestinal disorders	Roflumilast	1	11	1
other	Diarrhea	Gastrointestinal disorders	Placebo	0	16	0
other	Diarrhea	Gastrointestinal disorders	Roflumilast	1	11	1
other	weight loss of 10lbs	Metabolism and nutrition disorders	Placebo	0	16	0
other	weight loss of 10lbs	Metabolism and nutrition disorders	Roflumilast	1	11	1
other	upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Placebo	2	16	2
other	upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Roflumilast	1	11	1
other	cough	Respiratory, thoracic and mediastinal disorders	Placebo	0	16	0
other	cough	Respiratory, thoracic and mediastinal disorders	Roflumilast	1	11	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 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	4	16
Total, other adverse events	Roflumilast	5	11
Total, serious adverse events	Placebo	0	16
Total, serious adverse events	Roflumilast	0	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26151090	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
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/NCT01572948

GET https://conductscience.org/api/trials/v1/NCT01572948/registered

API reference For AI assistants