Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis
• Intervention / Treatment: Drug: Habitrol; 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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry	changes in forced vital capacity (FVC)	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
computed tomography (CT)	image analysis to detect common manifestations and its forced correlations with FVC	28 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: The Cleveland Clinic

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2015
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2014H0291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan in place to share IPD