N/A
N=27
A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)
COPD
Bottom Line
View on ClinicalTrials.gov: NCT01572948 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline — 0.74; 0.64 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- roflumilast (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2014
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 | — |
| SECONDARY Induced Sputum Neutrophil Count |
86; 58 | — |
| SECONDARY Induced Sputum Neutrophil Count |
86; 58 | — |
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.
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.
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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.