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

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
roflumilast
placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • UAB Lung Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Daliresp

Arm Description

The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.

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

Outcomes

Primary Outcome Measures

Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization

Secondary Outcome Measures

Induced Sputum Neutrophil Count
Induced Sputum Neutrophil Count
Induced Sputum Neutrophil Count

Full Information

First Posted
April 4, 2012
Last Updated
September 28, 2015
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01572948
Brief Title
A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.
Arm Title
Daliresp
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
roflumilast
Other Intervention Name(s)
Daliresp
Intervention Description
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 Type
Drug
Intervention Name(s)
placebo
Intervention Description
The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
Primary Outcome Measure Information:
Title
Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline
Time Frame
baseline
Title
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.
Time Frame
1 month after baseline
Title
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization
Time Frame
3 months after baseline
Secondary Outcome Measure Information:
Title
Induced Sputum Neutrophil Count
Time Frame
1 month
Title
Induced Sputum Neutrophil Count
Time Frame
baseline
Title
Induced Sputum Neutrophil Count
Time Frame
3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 HIV Solid organ transplant Active malignancy Systemic corticosteroid use ≥ prednisone 20mg / day Other immunosuppressants 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Blalock, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26151090
Citation
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.
Results Reference
derived

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

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