Clinical Trial: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Brief Summary: The purpose of this study is to determine if nicotine treatment is beneficial for the treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to inflammation. This disease affects your body's organs.

Detailed Summary:

Participants will be randomly divided into two groups. One group will receive a nicotine patch to use for approximately 7 months; the other group will receive placebo for nicotine patches to use for the same time period.

Both groups will be contacted weekly by phone for the first 3 weeks then monthly for the duration of the study to monitor for any side effects.

The following information and samples will be collected:

Questionnaires Medical History Spirometry CT Scans Physical Exam Blood Samples for nicotine and nicotine metabolites


Sponsor: Ohio State University

Current Primary Outcome: Spirometry [ Time Frame: 28 weeks ]

changes in forced vital capacity (FVC)


Original Primary Outcome: Same as current

Current Secondary Outcome: computed tomography (CT) [ Time Frame: 28 weeks ]

image analysis to detect common manifestations and its forced correlations with FVC


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: October 10, 2014
Date Started: October 2014
Date Completion: October 2019
Last Updated: January 9, 2017
Last Verified: January 2017