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

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ClinicalTrials.gov Identifier: NCT01572948
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : July 31, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Drug: roflumilast Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.
Drug: placebo
The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
Active Comparator: Daliresp
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
Drug: 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
Other Name: Daliresp



Primary Outcome Measures :
  1. Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline [ Time Frame: baseline ]
  2. Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. [ Time Frame: 1 month after baseline ]
  3. Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization [ Time Frame: 3 months after baseline ]

Secondary Outcome Measures :
  1. Induced Sputum Neutrophil Count [ Time Frame: 1 month ]
  2. Induced Sputum Neutrophil Count [ Time Frame: baseline ]
  3. Induced Sputum Neutrophil Count [ Time Frame: 3 months after baseline ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    Post-bronchodilator FEV1/FVC < 70% Post-bronchodilator FEV1 < 70% predicted

  3. Cigarette consumption of 10 pack-years or more. Patients may be active smokers.
  4. The presence of chronic cough and sputum production
  5. Willingness to make return visits and telephone availability for the study duration

Exclusion Criteria:

  1. A diagnosis of asthma as established by the study investigator on the basis of the recent American Thoracic Society/European Respiratory Society guidelines
  2. Clinically significant bronchiectasis
  3. Oxygen use >12 hours/day
  4. Known sensitivity to roflumilast
  5. Use of other methylxanthines within 1 month (theophylline)
  6. Changes to current maintenance COPD therapy within one month
  7. Pregnancy
  8. An acute illness requiring antibiotics and/or corticosteroids within the month prior to enrolment.
  9. Immunosuppression

    1. HIV
    2. Solid organ transplant
    3. Active malignancy
    4. Systemic corticosteroid use ≥ prednisone 20mg / day
    5. Other immunosuppressants
  10. Terminal illness defined as anticipated survival <12 months
  11. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572948


Locations
United States, Alabama
UAB Lung Health Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: James E Blalock, PhD University of Alabama at Birmingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J Edwin Blalock, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01572948     History of Changes
Other Study ID Numbers: DAL-MD-01
First Posted: April 6, 2012    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: October 19, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases