Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

NCT02097992 | Completed Phase 1 Results DMC

• 2 other identifiers: 20120591DAL-IT-06
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the proposed study are to determine 1) the effect of a single dose of Roflumilast on airway blood flow (Qaw) (study period 1) and 2) the effect of long-term Roflumilast treatment on airway blood flow reactivity delta Qaw)(study period 2) in patients with stable COPD who use ICS regularly.

Conditions

COPD

Keywords

COPD; airway blood flow

Outcome Measures

Primary Outcomes (1)

• Airway Blood Flow Reactivity (Delta Qaw)

  percentage of change on airway blood flow induced by albuterol.

  Immediate or 4 weeks

Study Arms (4)

SD placebo and MD roflumilast then MD placebo

EXPERIMENTAL

Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.

Drug: Roflumilast Placebo; Drug: Roflumilast

SD placebo and MD placebo then MD roflumilast

EXPERIMENTAL

Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.

Drug: Roflumilast Placebo; Drug: Roflumilast

SD roflumilast and MD placebo then MD roflumilast.

EXPERIMENTAL

Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.

Drug: Roflumilast Placebo; Drug: Roflumilast

SD roflumilast and MD roflumilast then MD placebo

EXPERIMENTAL

Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily

Drug: Roflumilast Placebo; Drug: Roflumilast

Interventions

Roflumilast Placebo DRUG

Placebo pill

SD placebo and MD placebo then MD roflumilast; SD placebo and MD roflumilast then MD placebo; SD roflumilast and MD placebo then MD roflumilast.; SD roflumilast and MD roflumilast then MD placebo

Roflumilast DRUG

500 Ug ORAL TABLET

Also known as: Daliresp

SD placebo and MD placebo then MD roflumilast; SD placebo and MD roflumilast then MD placebo; SD roflumilast and MD placebo then MD roflumilast.; SD roflumilast and MD roflumilast then MD placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty-four patients with physician-diagnosed COPD (female and male, current smokers or ex-smokers) over the age of 45 years will be recruited for this study.
• The patients will have to have a smoking history of at least 10 pack-years, and they must have been using an ICS regularly for at least 4 weeks at the time of screening.
• Confirmation of the diagnosis of COPD will require the presence of persistent exertional dyspnea and a post-bronchodilator FEV1 of less than 80% of predicted and FEV1/FVC ratio less than 0.7 (GOLD stage ≥2). At entry into the study, the patients will have to be clinically stable; they will be allowed to remain on their regular COPD treatment regimen and use a LABA and/or LAMA until 24 hours before, and a SABA and/or short-acting muscarinic antagonist (SAMA) until 6 hours before coming to the laboratory. If using roflumilast, the subjects will have to discontinue it 4 weeks before entering into the study.-

You may not qualify if:

• Women of childbearing potential who do not use accepted birth control measures
• Pregnant and breast-feeding women.
• Use of cardiovascular medications that cannot be held on the study days
• Use of oral airway medications or anti-inflammatory agents
• Use of supplemental oxygen that cannot be discontinued during the laboratory visit
• Subjects with known SABA or roflumilast intolerance
• An acute COPD exacerbation within four weeks prior to the study

Sponsors & Collaborators

• University of Miami: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Miami Divison of Pulmonary and Critical Care Medicine

Miami, Florida, 33136, United States

Location

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

The number of patients enrolled was lower than expected.

Results Point of Contact

• Title: Adam Wanner
• Organization: University of Miami

awanner@med.miami.edu

(305)243-3045

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: March 27, 2014
• Study Start: February 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 24, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-10

Locations

US (1)