NCT00701207

Brief Summary

The purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease. We want to see if people with sarcoidosis have a different immune response to those people without disease. The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2008

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

June 17, 2008

Last Update Submit

November 1, 2021

Conditions

Pulmonary Sarcoidosis

Keywords

To determine if nicotine treatment reduces lung inflammation

Outcome Measures

Primary Outcomes (1)

  • To determine if nicotine treatment reduces lung inflammation.

    Normalization of immune response

    3 months

Secondary Outcomes (1)

  • To determine if expression of α7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis.

    3 months

Study Arms (3)

2.

NO INTERVENTION

control group-no intervention

3

NO INTERVENTION

Healthy control group-blood and sputum samples

1.

EXPERIMENTAL

nicotine patch; transdermal patch 7mg, 14 mg., 21 mg. 3 months

Drug: nicotine patch

Interventions

nicotine patchDRUG

daily transdermal patch 7 mg, 14mg, 21 mg. 3 months

Also known as: Habitrol QC
1.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic (active) granulomatous lung disease (radiographic stage II or III disease) at least 6 months after the diagnosis. This selects patients that have the chronically active variant of sarcoidosis and will likely require long-term treatment (33).

You may not qualify if:

  • Active smokers,
  • Previous splenectomy,
  • Those requiring high-dose immunosuppression \[i.e., ≥ 0.2 mg/kg/day prednisone (or equivalent) or \> 10 mg/week methotrexate or requires second line cytolytic agents (e.g., cyclophosphamide, azathioprine) or anti-TNF treatments (e.g., thalidomide, anti-TNF antibodies, etc.)\] to control disease activity.
  • We will also exclude patients at high risk of complications relating to the use of nicotine. This will include patients with a known intolerance of nicotine or those with active cardiac or central nervous system disease who are at higher risk of cardiac arrhythmias or seizures.
  • We will also exclude patients with extensive pulmonary fibrosis based upon lung biopsy or high resolution CT scan criterion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Julian MW, Shao G, Schlesinger LS, Huang Q, Cosmar DG, Bhatt NY, Culver DA, Baughman RP, Wood KL, Crouser ED. Nicotine treatment improves Toll-like receptor 2 and Toll-like receptor 9 responsiveness in active pulmonary sarcoidosis. Chest. 2013 Feb 1;143(2):461-470. doi: 10.1378/chest.12-0383.

    PMID: 22878868BACKGROUND

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Elliott D. Crouser, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director, Intensive Care Unit, UHE

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

July 1, 2008

Primary Completion

December 31, 2010

Study Completion

December 31, 2010

Last Updated

November 8, 2021

Record last verified: 2021-11

Locations

US(1)