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Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

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ClinicalTrials.gov Identifier: NCT02265874
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : November 3, 2021
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Elliott Crouser MD, Ohio State University

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 16, 2014
Last Update Posted Date November 3, 2021
Actual Study Start Date  ICMJE January 12, 2015
Actual Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Spirometry [ Time Frame: 28 weeks ]
changes in forced vital capacity (FVC)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
computed tomography (CT) [ Time Frame: 28 weeks ]
image analysis to detect common manifestations and its forced correlations with FVC
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
Official Title  ICMJE Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sarcoidosis
Intervention  ICMJE
  • Drug: Habitrol
    Patch used daily for 28 weeks
  • Drug: Placebo to Habitrol
Study Arms  ICMJE
  • Active Comparator: Treatment
    Habitrol Nicotine patch - 7,14,21 mg patches Qd
    Intervention: Drug: Habitrol
  • Placebo Comparator: Control
    Placebo patch
    Intervention: Drug: Placebo to Habitrol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2021)
57
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2014)
60
Actual Study Completion Date  ICMJE November 1, 2021
Actual Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02265874
Other Study ID Numbers  ICMJE 2014H0291
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elliott Crouser MD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP