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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Habitrol Nicotine patch - 7,14,21 mg patches Qd |
|
| Control | Placebo Comparator | Placebo patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Habitrol | Drug | Patch used daily for 28 weeks |
| |
| Placebo to Habitrol |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity (FVC) | changes in forced vital capacity (FVC) measured by pulmonary function testing (breathing tests) measured in liters | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes Detected by Computed Tomography (CT) of Lungs | CT lung scans are analyzed by a computer program: Briefly, lung architecture, manifest as pixelated Houndsfield units, is assessed for regional mismatches (texture), wherein linear conformation of pixels are removed (equating with airways, blood or lymphatic vessels) and the mismatched pixels are quantified (i.e., Lung Texture Score; LTS) and are reflective of lung anatomy, including lung nodules, interstitial fibrosis or alveolar ground glass (i.e., pulmonary sarcoidosis manifestations). LTS is represented by arbitrary units, and are reported to range from 25 - 70; 25-40 being within the normal range (i.e., normal lung anatomy; and values in the 40 - 70 range are associated lung parenchymal disease (PMID: 22628482). |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600 | Columbus | Ohio | 43221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34029565 | Result | 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. | |
| 33089005 | 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. |
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There is no plan in place to share IPD
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Patients were screened for lung fibrosis and for cardiac involvement of sarcoidosis and were excluded if these were present
January 2015 through January 2019 from The Ohio State University Medical Center and from Cleveland Clinic Foundation
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| ID | Title | Description |
|---|---|---|
| FG000 | Habitrol | Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks |
| FG001 | Placebo | Placebo patch - 7,14,21 mg patches Qd Placebo to Habitrol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Habitrol | Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks |
| BG001 | Placebo | Placebo patch - 7,14,21 mg patches Qd Placebo to Habitrol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Forced Vital Capacity (FVC) | changes in forced vital capacity (FVC) measured by pulmonary function testing (breathing tests) measured in liters | Change in FVC from baseline to week 28 (study completion) in Habitrol treatment group compared to Placebo treatment group. | Posted | Mean | Standard Error | liters | 28 weeks |
|
Adverse events were recorded over a period of 6 months for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliott Crouser | The Ohio State University Wexner Medical Center | 16142934925 | elliott.crouser@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2018 | Apr 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2019 | Apr 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Drug |
|
| 28 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Changes Detected by Computed Tomography (CT) of Lungs | CT lung scans are analyzed by a computer program: Briefly, lung architecture, manifest as pixelated Houndsfield units, is assessed for regional mismatches (texture), wherein linear conformation of pixels are removed (equating with airways, blood or lymphatic vessels) and the mismatched pixels are quantified (i.e., Lung Texture Score; LTS) and are reflective of lung anatomy, including lung nodules, interstitial fibrosis or alveolar ground glass (i.e., pulmonary sarcoidosis manifestations). LTS is represented by arbitrary units, and are reported to range from 25 - 70; 25-40 being within the normal range (i.e., normal lung anatomy; and values in the 40 - 70 range are associated lung parenchymal disease (PMID: 22628482). | Change in lung texture score from baseline to study completion in the Habitrol treatment group compared to the Placebo group. | Posted | Mean | Standard Deviation | score on a scale | 28 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 6 |
| 24 |
| EG001 | Control | Placebo patch Placebo to Habitrol | 0 | 26 | 0 | 26 | 2 | 26 |
| Headache | Nervous system disorders | Non-systematic Assessment | Headache without neurological impairment |
|
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |