Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

NCT02265874 | Completed Phase 1 Results DMC

• 1 other identifier: 2014H0291
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Forced Vital Capacity (FVC)

  changes in forced vital capacity (FVC) measured by pulmonary function testing (breathing tests) measured in liters

  28 weeks

Secondary Outcomes (1)

• Changes Detected by Computed Tomography (CT) of Lungs

  28 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Habitrol Nicotine patch - 7,14,21 mg patches Qd

Drug: Habitrol

Control

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo to Habitrol

Interventions

Habitrol DRUG

Patch used daily for 28 weeks

Treatment

Placebo to Habitrol DRUG

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600

Columbus, Ohio, 43221, United States

Location

Related Publications (2)

• Crouser ED, Smith RM, Culver DA, Julian MW, Martin K, Baran J, Diaz C, Erdal BS, Hade EM. A Pilot Randomized Trial of Transdermal Nicotine for Pulmonary Sarcoidosis. Chest. 2021 Oct;160(4):1340-1349. doi: 10.1016/j.chest.2021.05.031. Epub 2021 May 23.

  PMID: 34029565 RESULT

• Hade EM, Smith RM, Culver DA, Crouser ED. Design, rationale, and baseline characteristics of a pilot randomized clinical trial of nicotine treatment for pulmonary sarcoidosis. Contemp Clin Trials Commun. 2020 Oct 7;20:100669. doi: 10.1016/j.conctc.2020.100669. eCollection 2020 Dec.

  PMID: 33089005 RESULT

MeSH Terms

Conditions

Sarcoidosis

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Elliott Crouser
• Organization: The Ohio State University Wexner Medical Center

elliott.crouser@osumc.edu

16142934925

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 16, 2014
• Study Start: October 21, 2015
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)