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

This study is currently recruiting participants.
Verified March 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01572948
First received: April 4, 2012
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in mean induced sputum proline-glycine-proline (PGP) levels at 3 months after randomization. [ Time Frame: screening, month 1 and month 3 ] [ Designated as safety issue: No ]
    The primary outcome of the study will be the change in mean induced sputum proline-glycine-proline (PGP) levels at 3 months after randomization.


Secondary Outcome Measures:
  • Induced sputum neutrophil counts [ Time Frame: screening, 1 month, 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572948

Contacts
Contact: Mark T Dransfield, MD 205-934-5555

Locations
United States, Alabama
UAB Lung Health Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mark T Dransfield, MD     205-934-5555        
Principal Investigator: Mark T Dransfield, MD            
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: James E Blalock, PhD University of Alabama at Birmingham
  More Information

No publications provided

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
Study First Received: April 4, 2012
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013