N/A Completed N=27 Randomized Triple-blind Treatment

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

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT01572948 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcomePrimary: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline — 0.74; 0.64 ng/ml

Summary

The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.

Outcome Measures

Outcome	Result	p-value
PRIMARY Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline	0.74; 0.64	—
PRIMARY Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.	.33; .66	—
PRIMARY Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization	0.70; 0.30	—
SECONDARY Induced Sputum Neutrophil Count	86; 58	—

Eligibility Criteria

Inclusion Criteria

Male and female subjects, > 40 years of age
Clinical diagnosis of moderate to severe COPD as defined by the GOLD criteria:

Post-bronchodilator FEV1/FVC 12 hours/day

Known sensitivity to roflumilast
Use of other methylxanthines within 1 month (theophylline)
Changes to current maintenance COPD therapy within one month
Pregnancy
An acute illness requiring antibiotics and/or corticosteroids within the month prior to enrolment.
Immunosuppression
HIV
Solid organ transplant
Active malignancy
Systemic corticosteroid use ≥ prednisone 20mg / day
Other immunosuppressants
Terminal illness defined as anticipated survival <12 months
Severe comorbidities including uncontrolled angina, congestive heart failure, end-stage renal disease, liver failure, or other conditions that would preclude the patient from safely completing the required tests or the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01572948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.