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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01572948
First received: April 4, 2012
Last updated: August 19, 2014
Last verified: August 2014

April 4, 2012
August 19, 2014
June 2012
June 2014   (final data collection date for primary outcome measure)
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.
Change in mean induced sputum 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 PGP levels at 3 months after randomization.
Complete list of historical versions of study NCT01572948 on ClinicalTrials.gov Archive Site
Induced sputum neutrophil counts [ Time Frame: screening, 1 month, 3 months ] [ Designated as safety issue: No ]
Induced sputum values of LTB4, MPO, LTA4H, TAP activity, IL-8, NE, [ Time Frame: screening, 1 month, 3 months ] [ Designated as safety issue: No ]
Secondary outcomes will include the induced sputum values of LTB4, MPO, LTA4H, TAP activity, IL-8, NE, and sputum neutrophil counts;
Not Provided
Not Provided
 
A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)
A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
COPD
  • 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
  • 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
  • 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.
    Intervention: Drug: placebo
  • 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
    Intervention: Drug: roflumilast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2014
June 2014   (final data collection date for primary outcome measure)

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.

    -

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572948
DAL-MD-01
No
University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: James E Blalock, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP