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

The University of Alabama at Birmingham

Status: Completed

Conditions: COPD

Treatments: Drug: roflumilast; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01572948

DAL-MD-01

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Daliresp

Active Comparator group

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

Treatment:

Drug: roflumilast