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

NCT ID: NCT01572948

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

roflumilast

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Daliresp

Eligibility 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.

-

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

J Edwin Blalock

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James E Blalock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Lung Health Center

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26151090 (View on PubMed)

Other Identifiers

DAL-MD-01

Identifier Type: -

Identifier Source: org_study_id