Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Sarcoidosis Clinical Trial

Official title:

Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265874
• Other study ID #: 2014H0291
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 12, 2015
• Est. completion date: November 1, 2021

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• Habitrol
Patch used daily for 28 weeks
• Placebo to Habitrol

Locations

Country	Name	City	State
United States	Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.2020.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry	changes in forced vital capacity (FVC)	28 weeks
Secondary	computed tomography (CT)	image analysis to detect common manifestations and its forced correlations with FVC	28 weeks