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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01745848
Other study ID # PRO12060615
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received December 6, 2012
Last updated September 26, 2016
Start date February 2013
Est. completion date December 2016

Study information

Verified date September 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 26
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco exposure, airflow obstruction (FEV1/FVC < 0.70) with an FEV1 < 70%

- baseline sputum production at least some of the time as reported on the Saint George's Respiratory Questionnaire, and at least one exacerbation within the past year

Exclusion Criteria:

- Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates, calcitonin, parathyroid hormone)

- Subjects with a body mass index less than 18 or greater than 34

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Roflumilast


Locations

Country Name City State
United States Emphysema COPD Research Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary systemic markers of bone metabolism 30 days No
Secondary endothelial function 30 days No
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