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Trial record 1 of 1 for:    Cleveland Clinic | sarcoidosis and nicotine
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Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

This study is currently recruiting participants.
Verified January 2017 by Elliott Crouser MD, Ohio State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02265874
First Posted: October 16, 2014
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Elliott Crouser MD, Ohio State University
  Purpose
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.

Condition Intervention Phase
Sarcoidosis Drug: Habitrol Drug: Placebo to Habitrol Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Resource links provided by NLM:


Further study details as provided by Elliott Crouser MD, Ohio State University:

Primary Outcome Measures:
  • Spirometry [ Time Frame: 28 weeks ]
    changes in forced vital capacity (FVC)


Secondary Outcome Measures:
  • computed tomography (CT) [ Time Frame: 28 weeks ]
    image analysis to detect common manifestations and its forced correlations with FVC


Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
Habitrol Nicotine patch - 7,14,21 mg patches Qd
Drug: Habitrol
Patch used daily for 28 weeks
Placebo Comparator: Control
Placebo patch
Drug: Placebo to Habitrol

Detailed Description:

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female subjects ≥ 18 to ≤ 75 years of age will be screened for eligibility.
  • Eligible adult patients will have histologically proven sarcoidosis, diagnosed at least 6 months before screening, evidence of parenchymal disease on chest radiograph, an FVC between 50% and 85% of the predicted value, and a Medical Research Council dyspnea score (47) of at least grade 1.
  • Patients must have been treated with at least 10 mg/day of prednisone or equivalent or one or more immunomodulating agents (hydroxychloroquine, methotrexate, azathioprine, leflunomide) for >3 months before screening.
  • Doses of these medications must be stable for at least 1 month before study entry.
  • During the study, background medication regimen and doses are to remain stable.

Exclusion Criteria:

  • active tobacco smoking or use of smokeless tobacco products containing nicotine,
  • active cardiac or central nervous system disease,
  • history of adverse reaction to nicotine or nicotine-containing products,
  • patients with extensive irreversible pulmonary fibrosis (based upon lung biopsy or high resolution CT scan criterion) or inability to provide consent.

The subject will be excluded if they have a smoking history of greater than 20 pack years, or a diagnosis of other significant respiratory disorder other, than sarcoidosis that, in the opinion of the investigator, would complicate the evaluation of response to treatment; or, history of substance abuse (drugs or alcohol) within 3 years prior to screening or other circumstances (e.g., psychiatric disease) that could interfere with the subject's adherence to protocol requirements or increase their risk of drug (nicotine) dependence.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265874


Contacts
Contact: Karen Martin 614-293-4978 Karen.Martin@osumc.edu
Contact: Emily Robart 614-366-1388 Emily.Robart@osumc.edu

Locations
United States, Ohio
Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600 Recruiting
Columbus, Ohio, United States, 43221
Contact: Karen Martin    614-366-2934    Karen.Martin@osumc.edu   
Sponsors and Collaborators
Ohio State University
The Cleveland Clinic
  More Information

Responsible Party: Elliott Crouser MD, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT02265874     History of Changes
Other Study ID Numbers: 2014H0291
First Submitted: October 10, 2014
First Posted: October 16, 2014
Last Update Posted: January 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action