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

NCT01572948 | Completed Results

• 1 other identifier: DAL-MD-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline

  baseline

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

  1 month after baseline

• Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization

  3 months after baseline

Secondary Outcomes (3)

• Induced Sputum Neutrophil Count

  1 month

• Induced Sputum Neutrophil Count

  baseline

• Induced Sputum Neutrophil Count

  3 months after baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Daliresp

ACTIVE COMPARATOR

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

Drug: roflumilast

Interventions

roflumilast 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

Also known as: Daliresp

Daliresp

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Lung Health Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 26151090 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

small sample size and limited follow-up

Results Point of Contact

• Title: J. Michael Wells, M.D.
• Organization: University of Alabama at Birmingham, Division of Pulmonary, Allergy, and Critical Care Medicine

jmwells@uab.edu

205-934-6047

Study Officials

• James E Blalock, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 19, 2015
• Results First Posted: July 31, 2015

Record last verified: 2015-09

Locations

US (1)