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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient. |
|
| Daliresp | Active Comparator | The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roflumilast | Drug | The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models |
| Measure | Description | Time Frame |
|---|---|---|
| Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline | baseline | |
| Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. | 1 month after baseline | |
| Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization | 3 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Induced Sputum Neutrophil Count | 1 month | |
| Induced Sputum Neutrophil Count | baseline | |
| Induced Sputum Neutrophil Count |
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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 < 70% Post-bronchodilator FEV1 < 70% predicted
Cigarette consumption of 10 pack-years or more. Patients may be active smokers.
The presence of chronic cough and sputum production
Willingness to make return visits and telephone availability for the study duration
Exclusion Criteria:
A diagnosis of asthma as established by the study investigator on the basis of the recent American Thoracic Society/European Respiratory Society guidelines
Clinically significant bronchiectasis
Oxygen use >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
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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| Name | Affiliation | Role |
|---|---|---|
| James E Blalock, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Lung Health Center | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26151090 | Derived | Wells JM, Jackson PL, Viera L, Bhatt SP, Gautney J, Handley G, King RW, Xu X, Gaggar A, Bailey WC, Dransfield MT, Blalock JE. A Randomized, Placebo-controlled Trial of Roflumilast. Effect on Proline-Glycine-Proline and Neutrophilic Inflammation in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):934-42. doi: 10.1164/rccm.201503-0543OC. |
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Subjects were recruited from a single center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast | group randomized to 30 day supply of white tablet 500microgram |
| FG001 | Placebo | 500microgram white tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient |
| BG001 | Roflumilast |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline | Posted | Mean | Standard Deviation | ng/ml | baseline |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
small sample size and limited follow-up
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Michael Wells, M.D. | University of Alabama at Birmingham, Division of Pulmonary, Allergy, and Critical Care Medicine | 205-934-6047 | jmwells@uab.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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|
| placebo | Drug | The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient |
|
| 3 months after baseline |
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Induced Sputum Neutrophil Count | Posted | Mean | Standard Error | percentage of sputum neutrophils | 1 month |
|
|
|
| Primary | Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. | Posted | Mean | Standard Deviation | ng/ml | 1 month after baseline |
|
|
|
| Primary | Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization | Posted | Mean | Standard Deviation | ng/ml | 3 months after baseline |
|
|
|
| Secondary | Induced Sputum Neutrophil Count | Posted | Mean | Standard Error | percentage of sputum neutrophils | baseline |
|
|
|
| Secondary | Induced Sputum Neutrophil Count | Posted | Mean | Standard Error | percentage of sputum neutrophils | 3 months after baseline |
|
|
|
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | Roflumilast | roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models | 0 | 11 | 5 | 11 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| weight loss of 10lbs | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| pleurisy | Reproductive system and breast disorders | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| insomnia | Nervous system disorders | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |