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

COPD Clinical Trial

Official title:

A Placebo-controlled Trial of Roflumilast (Daliresp) on Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572948
• Other study ID #: DAL-MD-01
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: September 28, 2015
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	UAB Lung Health Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline		baseline	No
Primary	Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.		1 month after baseline	No
Primary	Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization		3 months after baseline	No
Secondary	Induced Sputum Neutrophil Count		1 month	No
Secondary	Induced Sputum Neutrophil Count		baseline	No
Secondary	Induced Sputum Neutrophil Count		3 months after baseline	No