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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572948
First Posted: April 6, 2012
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham
  Purpose
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 Intervention
COPD Drug: roflumilast Drug: placebo

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by J Edwin Blalock, University of Alabama at Birmingham:

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

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

Enrollment: 27
Study Start Date: June 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.

  Contacts and Locations
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
  More Information

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 Submitted: April 4, 2012
First Posted: April 6, 2012
Results First Submitted: May 29, 2015
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