NCT01701934

Brief Summary

The purpose of this study is to determine whether roflumilast can improve metabolic profile and reduce visceral adiposity in patients with chronic obstructive pulmonary disease (COPD).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2013

Typical duration for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

October 3, 2012

Last Update Submit

November 10, 2014

Conditions

Chronic Obstructive Pulmonary DiseaseMetabolic Syndrome

Keywords

COPDIntrabdominal adiposityBody compositionTriglyceridesCholesterol

Outcome Measures

Primary Outcomes (1)

  • Change in intrabdominal adiposity

    Measured by CT scan.

    At baseline and 6 months later

Secondary Outcomes (7)

  • Change in body mass index

    At baseline and 6 months later

  • Change in waist circumference

    At baseline and 6 months later

  • Change in waist-to-hip circumference ratio

    At baseline and 6 months later

  • Change in blood metabolic profile

    At baseline and 6 months later

  • Change in body composition

    At baseline and 6 months later

  • +2 more secondary outcomes

Study Arms (2)

Roflumilast

EXPERIMENTAL

Roflumilast 500 mcg, once daily for 6 months

Drug: Roflumilast

Placebo pill

PLACEBO COMPARATOR

Placebo pill, once daily for 6 months

Drug: Placebo

Interventions

RoflumilastDRUG

500 mcg, oral, once daily for 6 months

Also known as: DAXAS
Roflumilast
PlaceboDRUG

One placebo pill daily, for 6 months

Also known as: Inactive comparator
Placebo pill

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gave an informed consent
  • Forced expiratory volume in 1 second \< 80% predicted
  • Forced expiratory volume in 1 second / Forced vital capacity \< 70%
  • No exacerbation in the last 4 weeks
  • Current or ex-smoker
  • Smoking history of at least 10 pack/year
  • Body mass index of at least 25 kg/m2
  • Waist circumference of at least 94 cm
  • Fasting blood triglycerides of at least 1.7 mmol/L

You may not qualify if:

  • Any significant pulmonary pathology other than COPD
  • Under oxygen therapy more than 12 hours per day
  • More than 2 exacerbation episodes in the last 12 months
  • The patient is currently participating to the active phase of a rehabilitation program
  • Patient has been under roflumilast therapy prior to enrollment
  • Unstable hypertriglyceridemia or hypercholesterolemia
  • Under diabetes therapy (hypoglycemic agent or insulin)
  • Cancer history in the last 5 years (except basal cell carcinoma)
  • Moderate or severe hepatic impairment
  • Used prednisone or systemic corticosteroids in the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Hôpital régional de Saint-Jérôme

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Related Publications (7)

  • Sava F, Laviolette L, Bernard S, Breton MJ, Bourbeau J, Maltais F. The impact of obesity on walking and cycling performance and response to pulmonary rehabilitation in COPD. BMC Pulm Med. 2010 Nov 6;10:55. doi: 10.1186/1471-2466-10-55.

    PMID: 21054892BACKGROUND

  • Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.

    PMID: 17167477BACKGROUND

  • Sin DD, Man SF. Why are patients with chronic obstructive pulmonary disease at increased risk of cardiovascular diseases? The potential role of systemic inflammation in chronic obstructive pulmonary disease. Circulation. 2003 Mar 25;107(11):1514-9. doi: 10.1161/01.cir.0000056767.69054.b3.

    PMID: 12654609BACKGROUND

  • Marquis K, Maltais F, Duguay V, Bezeau AM, LeBlanc P, Jobin J, Poirier P. The metabolic syndrome in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2005 Jul-Aug;25(4):226-32; discussion 233-4. doi: 10.1097/00008483-200507000-00010.

    PMID: 16056071BACKGROUND

  • Lam KB, Jordan RE, Jiang CQ, Thomas GN, Miller MR, Zhang WS, Lam TH, Cheng KK, Adab P. Airflow obstruction and metabolic syndrome: the Guangzhou Biobank Cohort Study. Eur Respir J. 2010 Feb;35(2):317-23. doi: 10.1183/09031936.00024709. Epub 2009 Jul 2.

    PMID: 19574332BACKGROUND

  • Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.

    PMID: 19716961BACKGROUND

  • Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.

    PMID: 19716960BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMetabolic Syndrome

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • François Maltais, MD

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

CA(5)