Trial Outcomes & Findings for Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study (NCT NCT02265874)

NCT ID: NCT02265874

Last Updated: 2025-04-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 28 weeks
• Results posted on: 2025-04-24

Participant Flow

January 2015 through January 2019 from The Ohio State University Medical Center and from Cleveland Clinic Foundation

Patients were screened for lung fibrosis and for cardiac involvement of sarcoidosis and were excluded if these were present

Participant milestones

Measure	Habitrol Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks	Placebo Placebo patch - 7,14,21 mg patches Qd Placebo to Habitrol
Overall Study STARTED	24	26
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Baseline characteristics by cohort

Measure	Habitrol n=24 Participants Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks	Placebo n=26 Participants Placebo patch - 7,14,21 mg patches Qd Placebo to Habitrol	Total n=50 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 11.5 • n=5 Participants	55.8 years STANDARD_DEVIATION 8.0 • n=7 Participants	53.9 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Change in FVC from baseline to week 28 (study completion) in Habitrol treatment group compared to Placebo treatment group.

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

Outcome measures

Measure	Treatment n=20 Participants Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks	Control n=20 Participants Placebo patch Placebo to Habitrol
Forced Vital Capacity (FVC)	0.07 liters Standard Error 0.22	-0.07 liters Standard Error 0.04

SECONDARY outcome

Timeframe: 28 weeks

Population: Change in lung texture score from baseline to study completion in the Habitrol treatment group compared to the Placebo group.

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).

Outcome measures

Measure	Treatment n=20 Participants Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks	Control n=20 Participants Placebo patch Placebo to Habitrol
Changes Detected by Computed Tomography (CT) of Lungs	-1.0 score on a scale Standard Deviation 3.5	2.5 score on a scale Standard Deviation 3.5

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=24 participants at risk Habitrol Nicotine patch - 7,14,21 mg patches Qd Habitrol: Patch used daily for 28 weeks	Control n=26 participants at risk Placebo patch Placebo to Habitrol
Gastrointestinal disorders Nausea	25.0% 6/24 • Number of events 6 • Adverse events were recorded over a period of 6 months for each participant	7.7% 2/26 • Number of events 2 • Adverse events were recorded over a period of 6 months for each participant
Nervous system disorders Headache	25.0% 6/24 • Number of events 6 • Adverse events were recorded over a period of 6 months for each participant	7.7% 2/26 • Number of events 2 • Adverse events were recorded over a period of 6 months for each participant

Additional Information

Dr. Elliott Crouser

The Ohio State University Wexner Medical Center

Phone: 16142934925

Email: elliott.crouser@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place